MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for COOK 6 FRENCH manufactured by Cook.
[104470181]
Angiogram performed. Export catheter became stuck across the aortic bifurcation; unable to be manipulated back into the sheath. Short 8-french sheath placed then exchanged for long 8-french sheath and this was able to be tracked across the aortic bifurcation. Export catheter was then removed from groin. Sheath separated in half and fractured. All pieces retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076288 |
| MDR Report Key | 7395371 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-03-21 |
| Date Added to Maude | 2018-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK 6 FRENCH |
| Generic Name | ANSEL SHEATH 55 CM |
| Product Code | GCC |
| Date Received | 2018-04-03 |
| Returned To Mfg | 2018-03-30 |
| Lot Number | 8470843 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-03 |