MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-24 for LUSEE WIRE GUIDE WIRE 5J3-143 manufactured by Cordis Corp..
[13515]
Guide wire fractured during attempted percutaneous transluminal coronary angioplasty. Distal vessel could not be bypassed. Fractured tip retained in plaque wall and could not be retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24603 |
| MDR Report Key | 24603 |
| Date Received | 1995-07-24 |
| Date of Report | 1995-02-28 |
| Date of Event | 1995-01-09 |
| Date Added to Maude | 1995-08-18 |
| 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 | LUSEE WIRE GUIDE WIRE |
| Generic Name | GUIDE WIRE |
| Product Code | DGX |
| Date Received | 1995-07-24 |
| Model Number | 5J3-143 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | 014-180-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 24973 |
| Manufacturer | CORDIS CORP. |
| Manufacturer Address | MIAMI FL 33152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-24 |