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