FDA Adverse Event
Injury
Summary report: N
SHINOBI SGW
MDR report key: 448013
·
Received March 14, 2003
Report
- Report Number
- 1016427-2003-00060
- Event Type
- Injury
- Date Received
- March 14, 2003
- Date of Event
- February 13, 2003
- Report Date
- March 14, 2003
- Manufacturer
- CORDIS CORP. (MIAMI)
- Product Code
- DQX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
GUIDEWIRE FRACTURED AND REQUIRED REMOVAL WITH BASKET FORCEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHINOBI SGW | CARDIOLOGY WIRES & METALS | DQX | CORDIS CORP. (MIAMI) | NA | A0502224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |