MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,foreign,user facility report with the FDA on 2015-05-29 for INDY OTW VASCULAR RETRIEVER N/A INDY-8.0-35-100-40 manufactured by Cook Inc.
[16560917]
A (b)(6) male patient with a thoraco-abdominal aneurysm was candidate for a t-branch device and the strategy was to perform a staged procedure over a few week's time. During the procedure, a tapered thoracic component was implanted to prepare for the implantation of the t-branch, which will take place in a few weeks time. The patient had very tight access vessels and double punctures was used on the right side. One for the tx2 stentgraft in a 22 fr system and one for a separate 5 fr introducer in which an unknown measuring catheter was placed. To verify the position of the stentgraft before deploying, the user pulled back the measuring catheter. Due to high friction and a significant amount of force, the catheter broke in two pieces, with one piece left inside the body of the patient. To remove the broken catheter, the user created an access from the left side and used an indy snare to capture the tip of catheter, still in the aortic arch. An 8 fr introducer was used from the left side with the intention to retrieve the 5 fr measuring catheter. The user removed the introducer and attempted to pull out the catheter from the vessel with the snare. The user experienced high friction and kept adding more and more force to pull it out. Eventually the snare broke, just below the point where the four loops are attached together. The catheter was then snared and successfully retrieved with another snare from the right side. Last but not least the remaining part of the indy snare, still left iliac, was easily retrieved using vascular retrieval forceps. No section of the device remains inside the patient. The patient did not require any additional procedures, nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[16787107]
Patient code: removal of foreign body is not labeled. Material separation is not labeled. A review of the complaint history, instructions for use (ifu), quality control (qc), specifications and trends was conducted for the purpose of this investigation. The complaint device was not returned and images were not provided by the customer. A review of the manufacturing record does not indicate any instances of rework or non-conformance. All 25 units of the lot passed qc and were released. A visual inspection could not be conducted since the complaint device was not returned. Any conclusions are solely based upon the testimony provided by the customer. The patient had very tight access vessels and double punctures was used on the right side. One fort the tx2 stentgraft in a 22 fr system and one for a separate 5 fr introducer in which an unknown measuring catheter was placed. To verify the position of the stentgraft before deploying, the user pulled back the measuring catheter. Due to high friction and a significant amount of force, the catheter broke in two pieces, with one piece left inside the body of the patient. Access was gained from the left side and an indy snare to capture the tip of catheter up in the aortic arch. A new measuring catheter was placed from the left side access and the deployment of the tx2 proceeded well. The remainder of the 1st measurement catheter needed to be removed. An indy snare was used to try to pull it out of the left side access. The introducer on the right side was first removed and the measurement catheter was snared with the indy snare. There was a large amount of friction with more and more force being exerted on the indy snare. The snare broke just below the point where the four loops are attached together. The measurement catheter was then snared and successfully retrieved with a snare from the right side. The broken part of the indy snare, still in the left iliac, was easily retrieved using a vascular retrieval forceps. Qc documentation confirms the assembly and quality inspections of the devices were inspected ty specifications. The ifu states under precautions,? This product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.? It is likely that the physician exerted excessive force upon the snare causing it to break in vivo. No additional risk mitigation is required at this time. We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.
Patient Sequence No: 1, Text Type: N, H10
[40873202]
(b)(4). Event evaluation: a review of the complaint history, instructions for use (ifu), quality control (qc), specifications and trends was conducted for the purpose of this investigation. The product was returned and a evaluation was performed. The flexor sheath with inner catheter measured 100. 2 cm in length. One kink was noted 7. 5 cm from the proximal end. The inner catheter extended past flexor sheath. 7 cm at the distal end. The inner catheter distal end is absent. The 4-loop wire snare was also absent. A review of the manufacturing record does not indicate any instances of rework or non-conformance. Qc documentation confirms the assembly and quality inspections of the devices were inspected to specifications. The ifu states under precautions, "this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. " it is likely that the physician exerted excessive force upon the snare causing it to break in vivo. No additional risk mitigation is required at this time. We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.
Patient Sequence No: 1, Text Type: N, H10
[40873203]
A (b)(6) male patient with a thoraco-abdominal aneurysm was a candidate for a t-branch device and the strategy was to perform a staged procedure over a few week? S time. During the procedure, a tapered thoracic component was implanted to prepare for the implantation of the t-branch, which will take place in a few weeks time. The patient had a very tight access vessels and double punctures was used on the right side. One fort the tx2 stentgraft in a 22 fr system and one for a separate 5 fr introducer in which an unknown measuring catheter was placed. To verify the position of the stentgraft before deploying, the user pulled back the measuring catheter. Due to high friction and a significant amount of force, the catheter broke in two pieces, with one piece left inside the body of the patient. To remove the broken catheter, the user created an access from the left side and used an indy snare to capture the tip of catheter, still in the aortic arch. An 8 fr introducer was used from the left side with the intention to retrieve the 5 fr measuring catheter. The user removed the introducer and attempted to pull out the catheter from the vessel with the snare. The user experienced high friction and kept adding more and more force to pull it out. Eventually the snare broke, just below the point where the four loops are attached together. The catheter was then snared and successfully retrieved with another snare from the right side. Last but not least the remaining part of the indy snare, still left in the left iliac, was easily retrieved using vascular retrieval forceps. No section of the device remains inside the patient. The patient did not require any additional procedures, nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00310 |
| MDR Report Key | 4811811 |
| Report Source | 01,06,FOREIGN,USER FACILITY |
| Date Received | 2015-05-29 |
| Date of Report | 2015-04-29 |
| Date of Event | 2015-04-29 |
| Date Facility Aware | 2015-04-29 |
| Date Mfgr Received | 2015-04-29 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2015-06-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDY OTW VASCULAR RETRIEVER |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2015-05-29 |
| Model Number | N/A |
| Catalog Number | INDY-8.0-35-100-40 |
| Lot Number | 4213473 |
| ID Number | (01)00827002518360(17)160401(1 |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-29 |