MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for FLEXOR RAABE GUIDING SHEATH 5F X 55CM KCFW 5.0-38-55-RB-RAABE manufactured by Cook, Inc..
[138367520]
While removing the sheath, the sheath broke leaving a portion in the femoral artery requiring cut down of the artery to remove the broken piece resulting in an admission overnight for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084741 |
| MDR Report Key | 8403395 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-03-05 |
| Date Added to Maude | 2019-03-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | FLEXOR RAABE GUIDING SHEATH 5F X 55CM |
| Generic Name | ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FED |
| Date Received | 2019-03-07 |
| Model Number | KCFW 5.0-38-55-RB-RAABE |
| Lot Number | 9447703 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47402 US 47402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-07 |