FDA Adverse Event
Malfunction
Summary report: N
HI-TORQUE WHISPER VIEW EXTRA SUPPORT CS-J (ES CS-J) GUIDE WIRE
MDR report key: 1683396
·
Received May 7, 2010
Report
- Report Number
- 2124215-2010-07494
- Event Type
- Malfunction
- Date Received
- May 7, 2010
- Date of Event
- January 25, 2010
- Report Date
- May 7, 2010
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI-TORQUE WHISPER VIEW EXTRA SUPPORT CS-J (ES CS-J) GUIDE WIRE | GUIDE WIRE | DTB | GUIDANT PUERTO RICO BV | 4635 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |