FDA Adverse Event
Malfunction
Summary report: N
AUTOTOME RX SPHINCTEROTOME
MDR report key: 1170214
·
Received September 11, 2008
Report
- Report Number
- 3005099803-2008-04496
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 12, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K013153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE IS RETURNED TO THE FACILITY. THE RETURNED DEVICE EVALUATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE AUTOTOME RX SPHINCTEROTOME WAS BEING PREPPED AS NORMAL. WHEN FLUSHING, IT SEEMED LIKE THE TOME HAD SPLIT, AS THE CONTRAST WAS SPRAYING EVERYWHERE WHEN FLUSHED. THE PROCEDURE WAS COMPLETED BY USING A JAGTOME. THE PATIENT CONDITION WAS REPORTED AS "NO ISSUE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOTOME RX SPHINCTEROTOME | KNS | BOSTON SCIENTIFIC CORPORATION | M00545170 | 11878212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |