FDA Adverse Event
Injury
Summary report: N
COOK INC
MDR report key: 404430
·
Received June 25, 2002
Report
- Report Number
- 404430
- Event Type
- Injury
- Date Received
- June 25, 2002
- Date of Event
- June 20, 2002
- Report Date
- June 25, 2002
- Manufacturer
- *
- Product Code
- DQX
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
GUIDEWIRE LODGED IN ARTERY DURING PTCA. REQUIRED SURGICAL REMOVAL AND REPAIR OF SUPERFICIAL FEMORAL ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK INC | GUIDE WIRE | DQX | * | TSCF-35-145-3 | 1138531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |