MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER E2401-51 manufactured by Lemaitre Vascular, Inc..
[174295803]
The cholangiogram catheter tip bubbled up at the end and could not be inserted. A new catheter had to be opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9568647 |
| MDR Report Key | 9568647 |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-21 |
| Date of Event | 2019-11-21 |
| Report Date | 2019-12-21 |
| Date Reported to FDA | 2019-12-21 |
| Date Reported to Mfgr | 2020-01-09 |
| Date Added to Maude | 2020-01-09 |
| 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 | REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER |
| Generic Name | CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2020-01-09 |
| Model Number | E2401-51 |
| Catalog Number | E2401-51 |
| Lot Number | RST2649 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |