FDA Adverse Event
Malfunction
Summary report: N
EXTRACTOR RX RETRIEVAL BALLOON
MDR report key: 554249
·
Received November 11, 2004
Report
- Report Number
- 6000122-2004-00007
- Event Type
- Malfunction
- Date Received
- November 11, 2004
- Date of Event
- September 13, 2004
- Report Date
- September 29, 2004
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CLINICIANS WERE USING THE DEVICE TO PERFORM THE THERAPEUTIC PROCEDURE OF REMOVING A CALCULUS FROM THE PT. DURING THE PROCEDURE THE BALLOON RUPTURED AT THE TARGET LESION, LEAVING BALLOON MATERIAL IN THE PT'S BILIARY DUCT. THE COMPLAINANT REPORTED THAT THE BALLOON MATERIAL WAS SUCCESSFULLY REMOVED WITH THE AID OF A SNARE. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE AFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTRACTOR RX RETRIEVAL BALLOON | STONE RETRIEVAL BALLOON | FGE | BOSTON SCIENTIFIC CORP. | NA | 6623374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |