MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for FOGARTY 120803F manufactured by Edwards Lifesciences Llc.
[181756298]
We are performing a femoral popliteal thrombectomy and using #3 fogarty catheter, the tip of the catheter broke off in the patient's artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9779695 |
| MDR Report Key | 9779695 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-22 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | FOGARTY |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-03 |
| Model Number | 120803F |
| Catalog Number | 120803F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |