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holly hess
PICC tip location systems

To anyone who is using a PICC tip location system such as the Sherlock or the Navigator: Have you ever or are you aware of anyone who has ever experienced a serious device failure such as a broken wire during insertion using one of these devices with a magnetic tip? Any other other serious events or complications?

Chris Cavanaugh
FDA MAUDE Database will tell you

Hi Holly, the FDA keeps a database of medical device failures.  Keep in mind, any one can report.  Some may be an educational issue or user error vs a true device failure, but you can see some of the issues if there have been any with any device.  Go to www.fda.gov and search MAUDE  and you can find the searchable database.

I would like to see more clinicians use this to report device failures, including catheters that malfunction, ultrasound machine malfunctions, etc.  Anyone can report into this and there is no fee. 

Chris

Chris Cavanaugh, RN, BSN, CRNI, VA-BC

holly hess
device failures

Chris,

I am wondering if I looked in the right place...I found the MAUDE database where there was only one report about a Sherlock which described a pt having transient shortness of breath which soon resolved. I couldn't find the wire fracture report mentioned in the thread on this site which they said was reported. That's why I was wondering if I had the wrong place.

Holly

DCrni
Did you try pulling the

Did you try pulling the stylet back and recalibrating?  If you calibrate while the tip is detectable by the sensor you will "zero it out" on the Sherlock.  I'm assuming your sherlock screen showed nothing as you advanced your catheter into place.

I've never had a tip not show up without a clear malfunction symbol on the sherlock. I have experienced plenty of cases where interference from electrical cords, chest leads, cell phones, call bell speakers, etc. have caused goofy readings.  I try to make certain all these things are out of the bed before starting to drape otherwise my assitant has to go on a hunt. 

Darilyn Cole, RN, CRNI, VA-BC
PICC Team Mercy General Hospital Sacramento, CA

 

Cherokee people
Navigator

We've been using the Navigator for 6 years at our hospital. We have 2 Navigators that we use. We place between 130-150 PICCs a month. We've never had any adverse effects using the Naviagator. We love it. We wouldn't place a PICC without it now.  We've had to send them back to the company a few times because they were not picking up the navion wire tip properly ( picked up in several areas). They would send us a refurbished one and we would mail the malfunctioning one back to them for repair. We have a contract with them. We don't get a new one usually it is a refurbished one. We've never had any problem working with the company they have always been very helpful. Hope this helps.

allanpd
Medical Device Failure

We recently experienced a very similar situation and did report it as a medical device failure. It is difficult though to know the exact cause. We contacted the product Rep and were told there had been a few other similar reports. It is a good reminder to check and document that your wire and stylet remain intact after the placement.

bartina
failure to detect wire

We use the Sherlock II.
The last PICC placed was not detected by the Sherlock. We weren't sure, but thought the tip looked different. We do not check the wire tips before insertion. I reported this to my sales rep but havne'nt had a response yet. Does everyone else check their tips before insertion?

Nancy Rose 

Gack
Navigator Experiences...

Hey Holly!

 

Just saw your question here so thought I would share my team's experience with the Navigator system.  We've been using Navigator here for several years...we were probably one of the first adopters actually.  We love it!  We have never had any serious device failures or broken wires.  Any time one of the hand-held units starts malfunctioning...they are very prompt in sending out a replacement unit and we get it the next day or 2 days max, then we ship back the faulty unit in the same box...prepaid.  We've only ever had to do this a few times over the several years of using Navigator.  Our wires have never broken on us.  The only thing we EVER had an issue with, with the wires, was a brief run where it seemed that a particular lot# had a problem with the lubricious (sp?) coating...the few involved wires just wouldn't thread into the catheters...this has been long resolved though and we've not had any problems for probably nearly 2 years now, I guess.  I would recommend Navigator to anyone w/o ANY hesitations whatsoever.  The product works and works well and the customer support is second to none!

 

Hope this helps!

 

Brian

Brian Gackenbach RN, BSN, CRNI

University of Louisville Hospital

brianga(at)ulh(dot)org

Robbin George
Answering Nancy Rose Before

Answering Nancy Rose

Before trimming the catheter make sure the wire is pulled back far enough to avoid cutting the tip of the wire [which is where Sherlock lives]

Tip axing can easily be done without realizing it

Everyone cuts off the Sherlock wire tip just once to learn this lesson

After you trim the catheter and thread the wire back into the PICC the wire will be longer then the catheter

You should use this opportunity to examine the tip

The first couple of mms are a lighter color then the rest of the wire and you can atleast confirm that Sherlock is present

Then pull the wire back into position and crimp the hub end of the wire to mark your spot

Robbin George RN Vascular Access Resource Dept Alexandria Hospital Virginia

Robbin George RN VA-BC

bartina
reply to Robin

Thanks for the advice. We do ensure the wire is pulled back more than enough before trimming. We just compared the wire from the faulty Sherlock experience to another wire, the magnetic tips are identical and present. Sounds like we might have a Sherlock problem. I appreciate your response. From now on, we will be examining our tips prior to insertion.

Nancy Rose 

holly hess
device failures

Nancy,

Did you have a wire fracture or just failure to detect?

Holly

Rhonda Wojtas
We have used SHerlock from

We have used SHerlock from the begining and I would never insert without it. As with any peice of equipment they Sherlock has had to be repaired or sent out as the sensors were not picking up the wire. The rep is very quick to help with that. Some time it has simply been there wasnt a good connnect at the usb port.

I find it have to believe that places do not use a tip location device whether it is Sherlock or any other device. Tip location devices save so much time and money. We have NO malpositions inthe IJ with SHerlock. That meant no repostioning lines and no repeat xray. I am patial to SHerlock because that is what I use.

As to wire fracture, I have never have ANY issue with wire fracutre since we began.

I love the Sherlock and can't wiat for the next one.

Rhonda Wojtas, RN VA-BC

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