FDA Adverse Event
Malfunction
Summary report: N
NAVIGATORTM HD
MDR report key: 3121804
·
Received May 21, 2013
Report
- Report Number
- 3005099803-2013-03703
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 30, 2013
- Report Date
- May 1, 2013
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- KOD
- PMA / PMN Number
- K122649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED DURING A URETEROSCOPY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHILE THEY ARE USING THE DEVICE RESISTANCE WAS FELT WHILE USING THE DEVICE. UPON REMOVAL OF THE DEVICE, ADDITIONAL FORCE WAS REQUIRED IN ORDER TO REMOVE THE DEVICE. IT WAS ALSO NOTED THAT THE COATING WAS INCONSISTENT AND NOT UNIFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224508 | NAVIGATORTM HD | CATHETER, UROLOGICAL | KOD | BOSTON SCIENTIFIC - SPENCER | M0062502220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 |