FDA Adverse Event
Malfunction
Summary report: N
HYDRATOME RX SPHINCTEROTOME
MDR report key: 1242896
·
Received November 19, 2008
Report
- Report Number
- 3005099803-2008-06571
- Event Type
- Malfunction
- Date Received
- November 19, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 20, 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
(DAMAGED TIP).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) USING THE HYDRATOME RX SPHINCTEROTOME, THE TIP OF THE DEVICE APPEARED "CHEWED UP". OCCLUSION CHOLANGIOGRAM WAS PERFORMED, UPON PULLING BACK THE TOME POST CANNULATION, THE SURGEON NOTED THAT TIP APPEARED DAMAGED (CHEWED UP). THOUGH NOT VISIBLE TO THE HUMAN EYE THE PHYSICIAN DID NOT WANT TO PROCEED. THE DEVICE WAS REMOVED IN ONE PIECE (TIP WAS NOT DETACHED) AND PROCEDURE COMPLETED WITH A DIFFERENT TOME. PATIENT IS REPORTED TO IN "STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRATOME RX SPHINCTEROTOME | KNS | BOSTON SCIENTIFIC CORPORATION | M00583050 | 11997618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |