FDA Adverse Event
Malfunction
Summary report: N
STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
MDR report key: 1414850
·
Received March 25, 2009
Report
- Report Number
- 3005099803-2009-01360
- Event Type
- Malfunction
- Date Received
- March 25, 2009
- Date of Event
- March 6, 2009
- Report Date
- March 9, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- FGO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A UROLOGICAL STONE RETRIEVAL PROCEDURE, THE BASKET WOULD NOT CLOSE. THE UNSPECIFIED TARGET STONE WAS IN AN UNSPECIFIED URINARY "DUCT". A STONE CONE 3 FRENCH 7MM CONE HAD BEEN ADVANCED TO RETRIEVE THE STONE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO CLOSE THE BASKET. THE DEVICE WAS PULLED BACK INTO THE UNSPECIFIED SCOPE "WITH RESISTANCE FELT". AFTER THAT, THE DISTAL PART WAS DETACHED IN THE SCOPE AND REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL | FGO | BOSTON SCIENTIFIC | M0063903100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |