FDA Adverse Event
Malfunction
Summary report: N
ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
MDR report key: 2760627
·
Received September 19, 2012
Report
- Report Number
- 1820334-2012-00437
- Event Type
- Malfunction
- Date Received
- September 19, 2012
- Date of Event
- August 6, 2012
- Report Date
- August 22, 2012
- Manufacturer
- COOK INC
- Product Code
- DQY
- PMA / PMN Number
- K073378
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE: BALLOON RUPTURE IS LISTED IN THE INSTRUCTIONS FOR USE. EVENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE PHYSICIAN ADVISED THAT HE WAS ATTEMPTING TO BALLOON ANGIOPLASTY A VERY CALCIFIED POPLITEAL ARTERY. HE INFLATED THE BALLOON USING THE RECOMMENDED PRESSURES AS STATED BY THE INSTRUCTIONS FOR USE. THE BALLOON BURST CIRCUMFERENTIALLY. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE BALLOON THROUGH THE FEMORAL SHEATH SO THE WHOLE THING HAD TO BE REMOVED. NO ILL EFFECT TO THE PATIENT. RECOVERED WELL POST PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE 18 LP LOW PROFILE BALLOON CATHETER | DQY CATHETER, PERCUTANEOUS | DQY | COOK INC | NA | 2856751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |