MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-01-23 for INDY OTW VASCULAR RETRIEVER INDY-8.0-35-100-40 manufactured by Cook, Inc..
[2421965]
The snare was inserted over a cook wire through another mfr's 10 fr sheath from the femoral artery into the thoracic aorta. Another mfr's 260 cm stiff wire was snared successfully (from the subclavian access above) within the wire loops of the snare. The anatomy was very challenging in terms of tortuosity and there was a degree of tension required to pull the other mfr's wire down to and through the femoral sheath. At the point where the snared wire reached the 10f sheath, the top portion of the wire basket detached from the main shaft. The dr was able to retrieve the wire basket from within the 10 fr sheath. Info was provided that no part of the device remained inside the pt and the pt did not require add'l procedures due to this occurrence. The complainant did not report any adverse effects on the pt due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[9589827]
(b)(4) - separates is not listed in the ifu. The customer returned one, used competitor's balloon along with the complaint device (product was returned in a used and damaged condition including the separated segment). Per spec, qc personnel verifies the surface of entire device is free of excessive dents, bumps, scratches, cracks and foreign matter. Tensile testing of this material established an average tensile strength and extension at break. The returned device does not appear to have undergone any sizeable extension; therefore, it is feasible to propose that the device catheter suffered some type of damage that resulted in a loss of integrity and reduction in its tensile strength. This complaint is more likely the result of user technique or handling prior to use. We will continue to monitor for similar complaints. Insufficient risk per quality engineering risk assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00078 |
| MDR Report Key | 2441721 |
| Report Source | 01,08 |
| Date Received | 2012-01-23 |
| Date of Report | 2012-01-10 |
| Date of Event | 2012-01-10 |
| Date Facility Aware | 2012-01-10 |
| Report Date | 2012-01-10 |
| Date Mfgr Received | 2012-01-10 |
| Device Manufacturer Date | 2011-10-15 |
| Date Added to Maude | 2012-03-05 |
| 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 | RITA HARDEN, MGR |
| 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 | 2012-01-23 |
| Returned To Mfg | 2012-01-17 |
| Model Number | NA |
| Catalog Number | INDY-8.0-35-100-40 |
| Lot Number | 2835406 |
| ID Number | NA |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-23 |