FDA Adverse Event
Malfunction
Summary report: N
STONE CONE NITINOL UTROLOGICAL RETRIEVAL COIL
MDR report key: 1173625
·
Received September 17, 2008
Report
- Report Number
- 3005099803-2008-04629
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Report Date
- August 22, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED STONE RETRIEVAL PROCEDURE, SHEATH RETRACTION DIFFICULTIES WERE ENCOUNTERED. THE LOCATION OF THE STONE IS UNKNOWN. UPON ADVANCING THE STONE CONE 3FR STONE RETRIEVAL BASKET TO THE STONE, THE SHEATH WAS UNABLE TO MOVE. IT WAS NOTED THAT THE DISTAL TIP OF THE DEVICE WAS COVERED WITH A BLUE SHEATH. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STONE CONE NITINOL UTROLOGICAL RETRIEVAL COIL | FGO DISLODGER, STONE, FLEXIBLE | FGO | BOSTON SCIENTIFIC CORPORATION | M0063903100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |