FDA Adverse Event
Injury
Summary report: N
SENSOR NITINOL WIRE WITH HYDROPHILIC TIP (STRAIGHT TIP)
MDR report key: 1894061
·
Received November 2, 2010
Report
- Report Number
- MW5018066
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- EZB
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING URETEROSCOPY, END OF GUIDEWIRE (HYDROPHILIC COATING) CAME OFF. THIS WAS RETRIEVED. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: LEFT URETERAL STONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSOR NITINOL WIRE WITH HYDROPHILIC TIP (STRAIGHT TIP) | SENSOR | EZB | BOSTON SCIENTIFIC | 670-305 | 13773502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |