MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-13 for RING DRAINAGE CATHETER NEEDLE SET DLPN-40-25-RING G03388 manufactured by Cook Medical.
[18978876]
The patient was in interventional radiology for embolization of an abdominal aortic aneurysm (aaa) endo leak. After multiple attempts the catheter fractured and 10 cm of catheter was left in the patient. Attempts to retrieve the retained catheter were unsuccessful. The patient has had no adverse outcomes to date and continues to be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2478431 |
| MDR Report Key | 2478431 |
| Date Received | 2012-02-13 |
| Date of Report | 2012-02-13 |
| Date of Event | 2012-02-07 |
| Report Date | 2012-02-13 |
| Date Reported to FDA | 2012-02-13 |
| Date Added to Maude | 2012-03-05 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RING DRAINAGE CATHETER NEEDLE SET |
| Generic Name | NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-02-13 |
| Model Number | DLPN-40-25-RING |
| Catalog Number | G03388 |
| Lot Number | 2543138 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IL * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-13 |