FDA Adverse Event
Malfunction
Summary report: N
CONQUEST PTA BALLOON DILATATION CATHETER
MDR report key: 2150386
·
Received June 8, 2011
Report
- Report Number
- 2020394-2011-00133
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 19, 2011
- Report Date
- May 19, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DQY
- PMA / PMN Number
- K014212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER SUCCESSFUL PTA WITHIN A DIALYSIS GRAFT, THE CATHETER BROKE DURING REMOVAL THROUGH THE INTRODUCER SHEATH. REPORTEDLY, DURING RETRACTION, THE BALLOON GOT CAUGHT ON THE TIP OF THE SHEATH. FORCE WAS APPLIED TO THE CATHETER, WHICH INITIALLY STRETCHED AND THEN BROKE, LODGING THE BALLOON INSIDE THE SHEATH. THE SHEATH AND BALLOON CATHETER WERE REMOVED TOGETHER. A NEW SHEATH AND PTA BALLOON CATHETER WERE ADVANCED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONQUEST PTA BALLOON DILATATION CATHETER | DQY | BARD PERIPHERAL VASCULAR, INC. | GFTG2076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |