FDA Adverse Event
Injury
Summary report: N
HI-TORQUE FLEXI-WIRE GUIDE WIRE
MDR report key: 641411
·
Received October 13, 2005
Report
- Report Number
- 2024168-2005-00441
- Event Type
- Injury
- Date Received
- October 13, 2005
- Date of Event
- September 16, 2005
- Report Date
- September 16, 2005
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- DQX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE DCA PROCEDURE, IT WAS CONFORMED VIA X-RAY, THAT THE GUIDE WIRE HAD SEPERATED IN THE PT. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPERATED PIECE OF THE GUIDE WIRE, BUT IT WAS STUCK IN THE RCA. THE PT WAS SENT TO SURGERY WHERE THE SEPERATED PIECE WAS SUCCESSFULLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI-TORQUE FLEXI-WIRE GUIDE WIRE | GUIDE WIRE | DQX | GUIDANT VASCULAR INTERVENTION | NA | 5032151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |