FDA Adverse Event
Injury
Summary report: N
CHOICE GUIDEWIRE
MDR report key: 2093747
·
Received May 18, 2011
Report
- Report Number
- 2134265-2011-01738
- Event Type
- Injury
- Date Received
- May 18, 2011
- Report Date
- April 20, 2011
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA
- Product Code
- DQX
- PMA / PMN Number
- K970244
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ON AN UNKNOWN DATE AND DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED INSIDE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHOICE GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - COSTA RICA | UNK499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |