FDA Adverse Event
Malfunction
Summary report: N
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
MDR report key: 2143268
·
Received June 28, 2011
Report
- Report Number
- 2939204-2011-00346
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 13, 2011
- Manufacturer
- BOSTON SCIENTIFIC - SALT LAKE CITY
- Product Code
- DQX
- PMA / PMN Number
- K032146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A SMALL PIECE OF THE COATING ON THE MID SECTION OF THE DEVICE DETACHED AS IT WAS BEING REMOVED FROM THE MICROCATHETER POST PROCEDURE. THE PIECE REMAINED INSIDE THE MICROCATHETER AND WAS SAFELY REMOVED. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - SALT LAKE CITY | M00313010 | B21312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXCELSIOR SL10 MICROCATHETER (BOSTON SCIENTIFIC) |