FDA Adverse Event Malfunction Summary report: N

MUSTANG?

MDR report key: 3881683 · Received June 18, 2014

Report

Report Number: 2134265-2014-03825
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: June 5, 2014
Report Date: June 10, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K110122
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTOR. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. THE 4.0MM X 40MM, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. THE BALLOON WAS FIRST INFLATED AT 15 ATMOSPHERES. HOWEVER ON THE SECOND INFLATION, WHEN THE BALLOON WAS INFLATED FOR 20 SECONDS AT 20 ATMOSPHERES, IT RUPTURED. THERE WAS NO KINK NOTED ON THE DEVICE PRIOR TO USE AND NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. THE BALLOON WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
358877	MUSTANG?	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	H74939171040470	0016012683

Patients

Seq	Age	Sex	Outcome	Treatment
1				INTRODUCER SHEATH: RADIFOCUS 4FR 10CM (TERUMO)\| GUIDE WIRE: RADIFOCUS 035 X 150 (TERUMO)