FDA Adverse Event
Malfunction
Summary report: N
STONETOME STONE REMOVAL DEVICE
MDR report key: 1133520
·
Received August 22, 2008
Report
- Report Number
- 3005099803-2008-03716
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- July 18, 2008
- Report Date
- July 24, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDI
- PMA / PMN Number
- K930092
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 24, 2008, THAT A STONETOME STONE REMOVAL DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE BALLOON BROKE DURING TESTING. THE PROCEDURE WAS COMPLETED WITH A SECOND STONETOME STONE REMOVAL DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STONETOME STONE REMOVAL DEVICE | FDI | BOSTON SCIENTIFIC CORPORATION | M00535110 | 0011058675 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |