FDA Adverse Event
Injury
Summary report: N
ZIPWIRE HYDROPHILIC GUIDEWIRE
MDR report key: 2001508
·
Received February 25, 2011
Report
- Report Number
- 3005099803-2011-00530
- Event Type
- Injury
- Date Received
- February 25, 2011
- Report Date
- February 3, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- DQX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZIPWIRE GUIDEWIRE WAS USED IN AN UNKNOWN PROCEDURE ON A PATIENT OF UNKNOWN AGE, SEX, AND WEIGHT.ACCORDING TO THE COMPLAINANT, WHEN PULLING THE WIRE BACK THE COATING OF THE WIRE PEELED OFF AND REMAINED IN THE KIDNEY. ONLY THE COATING REMAINED IN THE PATIENT. DURING AN X-RAY IT WAS SEEN THAT APPROXIMATELY 2-4CM OF THE COATING REMAINED IN THE PATIENT. THE PATIENT IS REPORTED TO BE "FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIPWIRE HYDROPHILIC GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - MARLBOROUGH | M006630222B0 | 2425003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |