FDA Adverse Event
Malfunction
Summary report: N
ZIPWIRE GUIDEWIRE
MDR report key: 745405
·
Received July 21, 2006
Report
- Report Number
- 6000130-2006-00191
- Event Type
- Malfunction
- Date Received
- July 21, 2006
- Date of Event
- June 23, 2006
- Report Date
- June 23, 2006
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
SAME CASE AS MFR'S REPORT # 6000089-2006-001509 AND 6000130-2006-00192. IT WAS REPORTED THAT DURING AN ILIAC STENT PLACEMENT TREATMENT PROCEDURE, THE DISTAL TIP OF THE ZIPWIRE GUIDEWIRE SHEARED OFF. A SECOND WIRE WAS USED TO COMPLETE THE CASE WITH NO PT COMPLICATIONS. CURRENT PT CONDITION IS REPORTED AS 'FINE'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIPWIRE GUIDEWIRE | GUIDEWIRE | DQX | BOSTON SCIENTIFIC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |