Forum topic

11 posts / 0 new
Last post
CCOOLE
Vaxcel PICC lines leaking

Has anyone had experience with BSI Vaxcel PICC line leaking due to a catheter developing a hole in it between the insertion site and the securing wing?    We have seen this happen to both the 4fr and 5fr single lumen catheters.    We had used Vaxcel PICC for several years and have since switched to Bard Solo PICC due to this problem.   On 2 occasions the lines were only in place for 24 hrs when they started leaking.    Initially thought this was a result of over pressurization during flushing but was later able to confirm with several patients's that this was not the case.  Reported to BSI, but never heard anything back from them on cause.  

afruitloop
Just yesterday a friend of
Just yesterday a friend of mine had a pt. with a PASV in develop a leak from the insertion site. After assessing for thrombosis around the catheter, which there was none, the catheter was pulled.  Upon insepecting the catheter, there was no leak with flushing.  Again, no thrombus in the vien was observed, as leakage of fluid form the entry site is classic symptom of thrombus.  He is sending the catheter back to the company for inpection.  He suspects a microscopic pin hole and the warmth of the blood allowed made the catheter more "pliable" thus allowing the leak.  ANy thoughts out there?

Cheryl Kelley RN BSN, VA-BC

lynncrni
A fibrin sheath could have

A fibrin sheath could have caused the fluid leakage. It would have stripped off the catheter when it was removed and would probably only be seen with a dye injection under fluoroscopy. How was the thrombosis assessment done - what test? 

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

Lynn Hadaway, M.Ed., NPD-BC, CRNI

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

afruitloop
The leak occurredform the

The leak occurredform the site with in hours of use. I think it would be very unsual for fibrin to encapsulte the catheter within 2-3 hours so completely  that this fluid leakage coud occur. 

Also with fibrin sheaths that encapsulate PICC's, I have been able to visuslize them near the point of PICC insertion after removal with the US.   They are sort of like in the "old days" when I used to wear knee socks and the elastic was stretched out of the top of them and they slid down my leg, bunching up at my ankles.  I picture that that is what a sheath does when the PICC is removed from the vessel and the sheath remains.  Many of you probably do not even know what knee socks are!  Now guess how old I am?  LOL

Cheryl Kelley RN BSN, VA-BC

Mike Brazunas
Chris, How’ve you been?

Chris,

How’ve you been?

 I agree with the other posts that it is most likely a fibrin sheath around the PICC.  It is very unusual for a PICC to develop a hole just under the skin (though not impossible).  I have seen this many times over the years.  While PICCs will blow at their weakest  point, the weakest point is usually where the tube meets the suture wings.  You can test this theory by carefuly trying to flush the PICC after it has been removed and looking for a hole.

Feel free to contact me.

Thanks,

Mike Brazunas RN

Clinical Specialist

Angiodynamics

[email protected]

 

Karen Day
Karen Day's picture
I have not had the

I have not had the experience of placing these lines myself, but my sister hospital has reported the same problem

 

CCOOLE
Actually the catheter itself

Actually the catheter itself had developed a hole in it about 1 cm from suture wing.    The hole was easily visible to naked eye.  I have seen leaking related fibrin sheath but this was actually a catheter defect that we have seen on several  occasions with this particular product.   I was really just trying to get a idea if other PICC Nurses had any similar experiences with Vaxcel PICC's having this same problem.   Our PICC team really didn't want to change products but after seeing several patients' had this same problem we were forced to make the change.  

 

Thanks,

Chris

lynncrni
Before you blame the

Before you blame the catheter and label it as a product defect, you need to look at the nursing practices in caring for these lines. Pin holes can be caused by excessive pressure applied to the catheter and this is caused by placing excessive force on the plunger of a syringe when flushing or giving meds through the catheter. It can happen with any size syringe but more pressure is generated with smaller syringes such as a 1 or 3 mL. Even with a 10 mL syringe, you can apply enough force to cause catheter damage if you are also meeting resistance in the fluid pathway. So when resistance is felt during a catheter flush, the standard is to stop and investigate why they are meeting resistance. A common mistake is to continue to apply force to the syringe plunger to overcome the resistance and this leads to catheter damage. So I think you may need some investigation of nursing knowledge and their techniques about this issue before you change products. It will happen with all catheters. So if this is the problem, changing to a different brand will not solve your problem.  

 

Lynn Hadaway, M.Ed., RN, BC, CRNI

www.hadawayassociates.com

Lynn Hadaway, M.Ed., NPD-BC, CRNI

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

CCOOLE
Lynn, After several of these

Lynn,

After several of these occurrences we did look at all the factors you mentioned and had previously passed the catheter problems off as Nursing care issues.    After these initial occurrences we had a period of 6 months where we didn't have any problems and then it started happening again (catheters with holes in them).   I was fortunate enough to have patients' with a nursing background on at least 2 of these occurrences.    And they both assured me that the catheters were cared for, flushed properly and never had any issues with either a partial or complete occlusion.    One of the catheters was only in place for 48 hrs and developed hole in it.  This may have just been a bad batch but couldn't see taking that chance and made change in brand.    No problems since change 6 months ago.

Thanks,

Chris Coole    

DML RN
You may be interested in the

You may be interested in the data found on the FDA's MAUDE site. There are hundreds of reports of leaking Vaxcel's,including a few that have noted defects in the catheters even before they are placed. Here's one example:

BOSTON SCIENTIFIC CORPORATION VAXCEL PICC VENOUS ACCESS SYSTEM   back to search results
Catalog Number 45-431
Device Problem Fracture(s) of device/material
Event Date 09/06/2006
Event Type  Malfunction  
Event Description

The complainant reported that during a therapeutic implant of a vaxcel picc in a male patient( age unk), the catheter was observed to have cracked. The crack was reported to be located distal to the device's suture wing. The clinician than obtained another device, but that device catheter also cracked in the same location of the first device (please reference attached medwatch report # 6000126-2006-00139). A third picc was obtained and was successfully implanted it in the patient. The complainant reported that was no adverse affect on the patient as a result of this reported problem.

Res ipsa loquitur.
Heather Nichols
   We have used the PASV

   We have used the PASV catheter for the last 3 years or so, and we have never had a problem with catheter fracture or holes.  We love that catheter, and the low maintenance they require.

    The FDA complaint was in 06, and did concern me, but I was told that Boston had since fixed the problem, and that it was mostly the 4 french catheters, not the 5 french. On the flip side, we used the Solo for 3 months and had a HORRIBLE time with it.  Isn't it weird how people have different problems with the same catheters?  It would seem to be user error if that is the case, but who knows.  PICC's are so unpredictable.

 

Log in or register to post comments