FDA Adverse Event
Malfunction
Summary report: N
AMPLATZ SUPER STIFF GUIDEWIRE
MDR report key: 1030705
·
Received April 15, 2008
Report
- Report Number
- 2134265-2008-01087
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 19, 2008
- Report Date
- March 19, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQX
- PMA / PMN Number
- K843012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GUIDE WIRE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE GUIDE WIRE COATING WAS NOTED TO BE "UNEVEN AND WORN OFF". THE EVENT OCCURRED OUTSIDE OF THE PT AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMPLATZ SUPER STIFF GUIDEWIRE | DQX WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC | NA | 11176550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |