FDA Adverse Event Injury Summary report: N

BOSTON SCIENTIFIC

MDR report key: 1832182 · Received September 7, 2010

Report

Report Number
MW5017335
Event Type
Injury
Date Received
September 7, 2010
Date of Event
September 2, 2010
Report Date
September 7, 2010
Manufacturer
BOSTON SCIENTIFIC, CORP. HEADQUARTERS
Product Code
KNY
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ON (B)(6)2010, PLACED NEPHROSTOMY DRAIN IN THE R KIDNEY OF PATIENT IN THE HEART AND VASCULAR LAB. ON (B)(6)2010, PLACED STARTER GUIDEWIRE .035/150 J CURVED FIXED CORE DOWN THE EXISTING NEPHROSTOMY DRAIN, DOWN THE URETER AND COILED APPROXIMATELY 10-15 CM IN THE BLADDER -REF: 49-119 LOT: M001491180-. THE PORTION OF THE WIRE THAT REMAINED OUTSIDE OF THEIR RIGHT FLANK AREA WAS THEN SECURED IN A STERILE FASHION. PATIENT WAS THEN SENT TO THE OPERATING ROOM. OR DEPT. CALLED FOR ASSISTANCE. THE WIRE ITSELF WAS DISSECTED/UNRAVELED. THE WIRE REMAINED OUTSIDE THE RIGHT FLANK AREA, THROUGH THE KUB, AS WELL AS RETROGRADE. SEVERAL METHODS WERE ATTEMPTED TO REMOVE WIRE. STENTS HAD TO BE PLACED IN ORDER TO REMOVE THE WIRE. BOSTON SCIENTIFIC WAS NOTIFIED REGARDING THE PROBLEM WITH THE WIRE. DATES OF USE: (B)(6)2010 -- (B)(6)2010. DIAGNOSIS OR REASON FOR USE: HYDRONEPHROSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BOSTON SCIENTIFIC STARTER GUIDEWIRE KNY BOSTON SCIENTIFIC, CORP. HEADQUARTERS M001491180

Patients

Seq Age Sex Outcome Treatment
1 78 YR Disability