MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-01-16 for TRACER METRO DIRECT WIRE GUIDE METII-35-480 manufactured by Wilson-cook Medical, Inc..
[367839]
During the procedure, the physician used a wilson-cook tracer metro direct wire guide. During use, the coating of the wire guide separated near the distal end and detached from the wire guide. The detached portion was left to pass naturally through the gastrointestinal tract. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2004-00009 |
| MDR Report Key | 512511 |
| Report Source | 08 |
| Date Received | 2004-01-16 |
| Date of Report | 2003-12-17 |
| Date Mfgr Received | 2003-12-17 |
| Date Added to Maude | 2004-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JESSICA HUGHES, MANAGER |
| Manufacturer Street | 4900 BETHANIA STATION ROAD |
| Manufacturer City | WINSTON SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACER METRO DIRECT WIRE GUIDE |
| Generic Name | COATED WIRE GUIDES |
| Product Code | EZM |
| Date Received | 2004-01-16 |
| Model Number | NA |
| Catalog Number | METII-35-480 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 501519 |
| Manufacturer | WILSON-COOK MEDICAL, INC. |
| Manufacturer Address | 4900 BETHANIA STATION RD. WINSTON-SALEM NC 27105 US |
| Baseline Brand Name | TRACER METRO WIRE GUIDE |
| Baseline Generic Name | COATED WIRE GUIDES |
| Baseline Model No | NA |
| Baseline Catalog No | METII-35-480 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-16 |