FDA Adverse Event
Injury
Summary report: N
WISDOM SGW
MDR report key: 416227
·
Received September 12, 2002
Report
- Report Number
- 1016427-2002-00165
- Event Type
- Injury
- Date Received
- September 12, 2002
- Date of Event
- August 15, 2002
- Report Date
- September 12, 2002
- Manufacturer
- CORDIS CORPORATION (MIAMI)
- Product Code
- DQX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE WIRE CURLED AND BENT. THERE WAS VESSEL DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WISDOM SGW | CARDIOLOGY WIRES & METALS | DQX | CORDIS CORPORATION (MIAMI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |