PASSPORT
Report
- Report Number
- 3005099803-2010-03753
- Event Type
- Malfunction
- Date Received
- September 1, 2010
- Date of Event
- August 11, 2010
- Report Date
- August 11, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- EZN
- PMA / PMN Number
- K941853
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
VISUAL AND TACTILE EVALUATION OF THE RETURNED DEVICE REVEALED NO DAMAGE TO THE SHAFT OF THE DEVICE. THE BALLOON WAS NOT FOLDED OR WRAPPED AROUND THE CORE WIRE. THE WIRE ON THE TIP OF THE DEVICE HAD BECOME ELONGATED AND UNRAVELED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT URETERAL BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FILAFORM TIP BECAME ELONGATED. THE BALLOON WORKED FINE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT URETERAL BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FILAFORM TIP BECAME ELONGATED. THE BALLOON WORKED FINE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PASSPORT | DILATOR, CATHETER, URETERAL | EZN | BOSTON SCIENTIFIC - GALWAY | M0062181100 | 13370482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |