FDA Adverse Event Death Summary report: N

BOSTON SCIENTIFIC

MDR report key: 623630 · Received July 21, 2005

Report

Report Number
623630
Event Type
Death
Date Received
July 21, 2005
Date of Event
July 12, 2005
Report Date
July 19, 2005
Manufacturer
BOSTON SCIENTIFIC
Product Code
DQX
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

DURING A CARDIAC CATH, THE PHYSICIAN USED AN XB 3.5 GUIDE CATHETER, A PT2 AND A PROWATER (BOTH 0.014" DIAMETER, 180 CM LONG WIRES) AND A MAVERICK 2.5 X 15 MM BALLOON TO DEFLECT THE GUIDE WIRE AWAY FROM THE SMALLER RAMUS BRANCH AND INTO THE LARGER, 99% STENOSED PART OF THE RAMUS. THE ANGULATION WAS SEVERE (CLOSE TO 80 DEGREES), AND, IN COMBINATION WITH THE SUBTOTAL OCCLUSION, MADE CROSSING OF THIS LESION VERY DIFFICULT. THE PHYSICIAN MADE A SECONDARY CURVE IN THE PT2 WIRE PRIOR TO INSERTING IT TO ACCOMODATE THE EXTREME ANGULATION OF THE TARGET VESSEL. THE ANGIOGRAPHIC RESULT WAS GOOD WITH LESS THAN 30% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PT2 GUIDE WIRE BROKE SOME TIME DURING THE DIFFICULT WIRE MANIPULATIONS AND WAS LODGED IN A VERY DISTAL PART OF THE RAMUS VASCULAR TERRITORY. ATTEMPTS TO RETRIEVE IT FAILED SINCE THE PHYSICIAN COULD NOT ADVANCE A NEW WIRE INTO THE REMOTE BRANCH OF THE ARTERY WHERE THE FRAGMENT TIP OF THE WIRE HAD EMBOLIZED. THERE WAS NO APPARENT VASCULAR CONTINUITY BETWEEN THE MAIN BRANCH AND THE SMALL DISTAL BRANCH OF THE TIP OF THE WIRE. THE PT DETERIORATED THAT NIGHT, AND EXPIRED IN 2005. THE CORONER HAS FOUND THAT THE CAUSE OF DEATH WAS CARDIAC TAMPONADE, RELATED TO HEMMORHAGING CAUSED BY THE TIP OF THE RETAINED WIRE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BOSTON SCIENTIFIC MODERATE SUPPORT GUIDE WIRE, PT2 .014" 185CM DQX BOSTON SCIENTIFIC * 7587361

Patients

Seq Age Sex Outcome Treatment
1 63 YR Death