FDA Adverse Event
Malfunction
Summary report: N
ZERO TIP NITINOL STONE RETRIEVAL BASKET
MDR report key: 1063023
·
Received June 19, 2008
Report
- Report Number
- 3005099803-2008-00777
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Report Date
- May 22, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFL
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL IMPRESSION OF THE DEVICE UPON RECEIPT IS "UNOPENED, BUT LONG CUT IN THE POUCH AND ON THE TRAY."
Description of Event or Problem · 1
IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING THE UNPACKING OF A ZERO TIP BASKET A "SPLIT ON THE TOP STERILE STRIP, AS IF CUT BY A SHARP OBJECT" WAS OBSERVED. ACCORDING TO THE COMPLAINANT, THIS WAS OBSERVED IN THE MAIN DELIVERY AREA AND DID NOT INVOLVE A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZERO TIP NITINOL STONE RETRIEVAL BASKET | FFL | BOSTON SCIENTIFIC CORPORATION | M0063901030 | 11527422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |