FDA Adverse Event Death Summary report: N

BOSTON SCIENTIFIC

MDR report key: 829915 · Received March 16, 2007

Report

Report Number
MW1042256
Event Type
Death
Date Received
March 16, 2007
Date of Event
March 13, 2007
Report Date
March 16, 2007
Manufacturer
*
Product Code
DQX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

DURING CORONARY ANGIOPLASTY A BOSTON SCIENTIFIC GUIDE WIRE WAS USED TO CANNULATE THE OBTUSE MARGINAL CORONARY ARTERY. THE VESSEL WAS DILATED. UPON ATTEMPT TO REMOVE THE GUIDEWIRE, A WIRE FRAGMENT SHEARED OFF. A SECOND CARDIOLOGIST THEN CANNULATED THE SAME VESSEL WITH A DIFFERENT SIZE BOSTON SCIENTIFIC GUIDEWIRE FOR AN ATTEMPT TO RETRIEVE THE FRAGMENT. WHEN UNABLE TO ACCOMPLISH, THE DECISION WAS MADE TO CONTAIN THE FRAGMENT BY STENTING OVER THE WIRE FRAGMENT. AGAIN UPON ATTEMPT TO REMOVE THE GUIDEWIRE, A WIRE FRAGMENT SHEARED OFF. A THIRD CARDIOLOGIST CANNULATED THE PATIENT AND DISCOVERED A MAJOR THROMBUS FROM THE LEFT MAIN CORONARY ARTERY, THE LEFT ANTERIOR DESCENDING AND OBTUSE MARGINAL ARTERY. THE CLINICAL CONDITION DETERIORATED TO A FATAL ARRHYTHMIA AND SUBSEQUENT DEATH. AUTOPSY DID NOT SHOW EVIDENCE OF VESSEL PERFORATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BOSTON SCIENTIFIC MODERATE SUPPORT CHOICE PT DQX * PT 2 GUIDEWIRE 9328523
2 * GUIDEWIRE DQX * * UNK

Patients

Seq Age Sex Outcome Treatment
1 66 YR Death CORONARY STENTS UNK AT TIME OF PRODUCTS