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Trerotola Device Issues

Posted By Terry Litchfield, Friday, April 26, 2019

Is anyone having issues with the tip of the Trerotola thrombectomy device separating from the basket portion?  Over the last year, we have seen several of these occur and note the MAUDE database is reporting many of them.  The tip is often not able to be retrieved.

The manufacturing changed to Mexico and there appears to be something happening.

And of course would want to make sure that anyone seeing a product defect should report the device failure to the manufacturer.  And please report additional catheters that have the same problem.  

Would love to hear if others are seeing this.

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Permalink | Comments (14)
 

Comments on this post...

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Haimanot Wasse says...
Posted Friday, April 26, 2019
Yes- I had two separate in the past 8 months and have stopped using them. I reported them to the company as device defects along with the lot numbers.
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Timothy O'Connor says...
Posted Saturday, April 27, 2019
The basket broke off in graft in pt treated elsewhere recently. Procedure terminated and graft thought failed. I saw pt a month later and surprisingly access was patent. Basket removed surgically.
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Harold R. Locay says...
Posted Saturday, April 27, 2019
I only use the Arrow Cleaner.
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Patrick Johnson says...
Posted Saturday, April 27, 2019
With the Cleaner, are you hesitant to use it despite having to give up wire access? Any suggestions? We use both, but rarely. I feel that the cleaner does work better than the treratola, but we hate losing access to use it.
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Gregg M. Gaylord says...
Posted Saturday, April 27, 2019
I prefer the Cleaner for it's efficacy not to mention ease of use and no longer use the Trerotola despite using it for nearly 20 years. As far as giving up access, If I am truly concerned about losing access, I will pass a long sheath past the clot over a wire and then deploy the Cleaner taking care not to withdraw it into a position of "no return". I rarely need to do this however as usually some sort of external manipulation of the access - retracting distally or medial/lateral or even centrally - resolves the issue.
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Harold R. Locay says...
Posted Sunday, April 28, 2019
Not very concerned losing wire access unless it’s early into the declot and PTA is done with only a pullback defining the anatomy. At that point an extrav may not be seen immediately. I usually reserve the cleaner after flow restored but there is resistant clot in an aneurysm all section usually the fistula body. At that point replacing the wire is not difficult. .
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Marc Webb says...
Posted Monday, July 29, 2019
I have had several of the flexible tips become disconnected from the rotating basket.
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Marc Webb says...
Posted Monday, July 29, 2019
I have had several of the flexible tips become disconnected from the rotating basket.
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Marc Webb says...
Posted Monday, July 29, 2019
I have had several of the flexible tips become disconnected from the rotating basket.
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Marc Webb says...
Posted Monday, July 29, 2019
I have had several of the flexible tips become disconnected from the rotating basket.
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Anil K. Agarwal says...
Posted Monday, July 29, 2019
We had a cleaner tip break as well!
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Shukhrat Artikov says...
Posted Monday, July 29, 2019
It sounds scary. Honestly, I have almost zero experience of using rotational devices and from time to time I was thinking if I need go get it just in case.
Thanks to all for sharing experience in this discussion. Based on this discussion, I will not accept Trerotola device even if it will be free of charge.
I am doing 10 to 20+ declots a month and all I use is dirt cheap Cordis Brite tip catheters, 2mg of TPA (very rarely 4mg or 6mg) and balloon maceration (8mm x 10 cm is my favorite). In rare cases of failure, it is not because of poor thrombus removal. On some occasions it is necessary to make hundreds of passes of aspiration catheter, but if to use two catheters and use one while technician is preparing second one, it rarely takes more than 20 minutes for pretty good thrombus debulking. It would be great if ASDIN meetings have serious discussions of our "tricks of the trade", we can discuss issues like this. All of us have different experience and we developed different ways of coping with the same problems, why not to share our experience instead of politely listening to the same basic lectures every year?
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George M. Nassar says...
Posted Tuesday, July 30, 2019
We had the tip of the over the wire Trerotola thrombectomy device separate and go proximal; we were able to retrieve it as it was on the guidewire by snaring the tip of the of the guidewire. However it was not a pleasant moment.
The basket of the Trerotola frequently gets entangled if there is a guidewire across which at times of difficult access, it necessary to keep.
Overall, I dislike using this device and given its expense, it dose not live to its expectations. An improved version of it needs to be designed.
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Wesley A. Gabbard says...
Posted Tuesday, July 30, 2019
It is interesting to read the comments associated with thrombectomy devices. It is much easier and faster to occlude the inflow and outflow and just express the thrombus from a fistula. This is, especially, true with aneurysmal fistulae with organized thrombus. If an interventionalist views a fistula after percutaneous thrombectomy with ultrasound, it is dreadfully disappointing at the amount of thrombus still within the lumen of the vessel. This is not seen as much with grafts. Sometimes such rotational devices are helpful in the outflow veins versus an angiojet, but I wonder if the breakdown of the device is due to overuse where it is not really indicated? Just a thought. Have a nice week!
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