FDA Adverse Event Malfunction Summary report: N

HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE

MDR report key: 6084924 · Received November 8, 2016

Report

Report Number
6084924
Event Type
Malfunction
Date Received
November 8, 2016
Date of Event
November 1, 2016
Report Date
November 4, 2016
Manufacturer
ABBOTT VASCULAR
Product Code
DQX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE FIRST WIRE WAS PLACED IN THE POSTERIOR DESCENDING ARTERY (PDA) DISTAL TO THE LESION, THE SECOND WAS ADVANCED BEYOND THE LESION AND PARKED IN THE POSTERIOR LEFT VENTRICULAR BRANCH (PLV) TO PROTECT IT IN CASE INTERVENTION CAUSED THE VESSEL TO SHUT DOWN. ONCE THIS WAS DONE, A 2.5 X 12 MM BALLOON WAS ADVANCED OVER THE PDA WIRE TO THE SITE OF THE LESION AND INFLATED TO 14 ATMOSPHERES. THE BALLOON WAS THEN WITHDRAWN. ANGIOGRAPHY SHOWED THE LESION HAD DILATED WELL. NEXT, A 3-0 X 16 MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED OVER THE SAME BARE METAL WIRE (BMW) WIRE THAT WAS PARKED IN THE PDA. IT WAS CAREFULLY POSITIONED TO COVER THE ENTIRE LESION LENGTH. IT WAS THEN DEPLOYED 10-12 ATMOSPHERES WITH THE AIM OF PULLING. ANGIOGRAPHY WAS PERFORMED THAT REVEALED EXCELLENT FLOW INTO THE PDA AND THE PLV WITH NO IMPINGEMENT OF THE PLV BRANCH. AT THIS POINT, AN ATTEMPT WAS MADE TO WITHDRAW THE BMW IN THE PLV. UNFORTUNATELY, THE BMW TRAPPED BEHIND THE STENT HAD UNRAVELED AND FRACTURED/BROKE BEHIND THE STENT. AN INITIAL ATTEMPT WAS MADE TO SNARE THE WIRE, BUT GIVEN THE FACT THAT THE PLV WAS SMALL DISTALLY WITH THE WIRE IN THE DISTAL PORTION OF THE PLV AND THE PROXIMAL PORTION OF THE BROKEN WIRE TRAPPED BEHIND THE STENT, ATTEMPTS TO SNARE IT AND WITHDRAW IT WOULD LIKELY JUST CAUSE MORE DAMAGE TO THE VESSEL, BUT LIKELY DISRUPTION AND SHUTTING DOWN OF THE VESSEL. THE PLV WAS EASILY WIRED WITH A WHISPER WIRE, BUT THEN AFTER CONFERRING WITH SECOND INTERVENTIONALIST, IT WAS DETERMINED THAT THE RISKS WOULD OUTWEIGH BENEFITS IN TRYING TO SNARE THE DISTAL PORTION OF THE BMW WIRE AND THEN WITHDRAW IT GIVEN THAT IT WAS TRAPPED UNDER THE STENT, WOULD LIKELY DISRUPT THE ENTIRE STENT AND POSSIBLY DISSECT THE RCA AND POTENTIALLY EVEN RUPTURE IT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
738060 HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR 0.014/190CM 6071471

Patients

Seq Age Sex Outcome Treatment
1 53 YR YES, THERE WAS A STENT BEING DEPLOYED.