FDA Adverse Event
Malfunction
Summary report: N
OCCLUSION BALLOON CATHETHER
MDR report key: 1722705
·
Received December 14, 2009
Report
- Report Number
- 2134265-2009-07057
- Event Type
- Malfunction
- Date Received
- December 14, 2009
- Date of Event
- December 2, 2009
- Report Date
- December 3, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQY
- PMA / PMN Number
- K062202
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OVER 60 YEARS OF AGE. (B) (4).
Description of Event or Problem · 1
SAME CASE AS MFR#: 2134265-2009-07058. IT WAS REPORTED THAT DURING A STONE REMOVAL PROCEDURE, TWO BALLOON RUPTURES OCCURRED. THE OCCLUSION BALLOON CATHETER WAS ADVANCED TO THE BILE DUCT TO AIDE IN THE REMOVAL OF A STONE FROM THE GALL BLADDER. UPON INFLATION, THE BALLOON OF THE DEVICE RUPTURED AT AN UNKNOWN DIAMETER BELOW 11.5MM. THE DEVICE WAS EXCHANGED FOR ANOTHER OCCLUSION BALLOON CATHETER. THE SECOND CATHETER WAS ADVANCED TO THE BILE DUCT, INFLATED, AND ALSO RUPTURED PRIOR TO REACHING 11.5MM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT OCCLUSION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS REPORTED AS "GOOD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCCLUSION BALLOON CATHETHER | DQY CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC | 17-301 | 12471641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |