FDA Adverse Event Malfunction Summary report: N

PVS 2000 SYNCHRO2 GUIDEWIRE

MDR report key: 2091245 · Received May 17, 2011

Report

Report Number: 2939204-2011-00301
Event Type: Malfunction
Date Received: May 17, 2011
Date of Event: April 7, 2011
Report Date: May 9, 2011
Manufacturer: BOSTON SCIENTIFIC - SALT LAKE CITY
Product Code: DQX
PMA / PMN Number: K053268
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE GUIDEWIRE AND TORQUE DEVICE WERE RETURNED FOR ANALYSIS. INSPECTION OF THE DEVICE FOUND THAT THE GUIDEWIRE HAD BEEN SHAPED AND WAS BENT ON THE DISTAL SECTION. INSPECTION OF THE DEVICE FOUND THAT THE PTFE COATING WAS SLIGHTLY COMPRESSED AND SCRAPED OFF THE CORE WIRE 32.5CM FROM THE PROXIMAL END. THE TORQUE DEVICE BRASS COLLETT MARKINGS WERE VISIBLE ON THE GUIDEWIRE. NO OTHER ANOMALIES WERE NOTED. THE DAMAGE NOTED TO THE PTFE COATING IS INDICATIVE THAT THE TORQUE DEVICE WAS NOT SECURELY ATTACHED TO THE DEVICE AND MOVED ALONG THE LENGTH OF THE DEVICE CAUSING THE OBSERVED DAMAGE. THE DIRECTIONS FOR USE SPECIFICALLY INSTRUCT THAT THE TORQUE DEVICE SHOULD BE SECURELY ATTACHED TO PREVENT SUCH DAMAGE FROM OCCURRING. THEREFORE, USE/USER ERROR IS THE MOST LIKELY CAUSE OF THE OBSERVED DAMAGE TO THE PTFE COATING.

Description of Event or Problem · 1

ANALYSIS OF THE RETURNED DEVICE REVEALED POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING OFF OF THE GUIDEWIRE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PVS 2000 SYNCHRO2 GUIDEWIRE	WIRE, GUIDE, CATHETER	DQX	BOSTON SCIENTIFIC - SALT LAKE CITY	M00326010	B22117

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR