FDA Adverse Event
Malfunction
Summary report: N
IMPULSE GUIDE CATHETERS
MDR report key: 1060071
·
Received June 11, 2008
Report
- Report Number
- 2134265-2008-01655
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Report Date
- May 19, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQO
- PMA / PMN Number
- K992142
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, "THE D 6F IMPULSE FL4 WAS WIPED DOWN WITH GAUZE AND A PURPLE RESIDUE CAME OFF ON THE GAUZE." IT WAS FURTHER REPORTED THAT THE DEVICE WAS DISPOSED AND ONLY THE GAUZE IS BEING RETURNED FOR ANALYSIS. THERE WAS NO PT CONTACT. ANOTHER OF THE SAME DEVICE WAS PREPPED AND USED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPULSE GUIDE CATHETERS | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | BOSTON SCIENTIFIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |