FDA Adverse Event
Malfunction
Summary report: N
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
MDR report key: 2152855
·
Received June 28, 2011
Report
- Report Number
- 1820334-2011-00329
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 30, 2011
- Manufacturer
- COOK INC
- Product Code
- DQY
- PMA / PMN Number
- K091527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION DATE UNK AS LOT IS UNK. PT OUTCOME WAS NOT PROVIDED BY THE REPORTER. BALLOON RUPTURE IS ADDRESSED IN THE SUPPLIED IFU. EVALUATION: EVENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
BALLOON BURST ON INFLATION FOR FIBROTIC GRAFT STENOSIS. IT MUST HAVE SPLIT CIRCUMFERENTIALLY RATHER THAN LONGITUDINALLY, BECAUSE SURGEON COULDN'T GET IT BACK INTO SHEATH. EVENTUALLY, MANAGED TO PULL SHEATH AND BALLOON OUT TOGETHER, AND SPLIT BALLOON HAD ROLLED BACK ON ITSELF TO FORM A 'DOUGHNUT' SHAPE, WHICH IS WHY IT WOULD NOT PULL INTO SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE 35 LP LOW PROFILE BALLOON CATHETER | DQY CATHETER, PERCUTANEOUS | DQY | COOK INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |