FDA Adverse Event Malfunction Summary report: N

MUSTANG¿

MDR report key: 2901482 · Received January 8, 2013

Report

Report Number: 2134265-2012-08241
Event Type: Malfunction
Date Received: January 8, 2013
Date of Event: December 10, 2012
Report Date: December 10, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: LIT
PMA / PMN Number: K103751
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. USING THE FEMORAL APPROACH, THE PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS ILIAC ARTERY. FOR PRE-DILATION, A 9.0X40MM MUSTANG BALLOON WAS ADVANCED FOR TREATMENT, HOWEVER THE BALLOON RUPTURED AT UNKNOWN ATMS. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF AN EXPRESS LD STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
8869	MUSTANG¿	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - GALWAY	H74939171090470	0015306228

Patients

Seq	Age	Sex	Outcome	Treatment
1				RADIFOCUS 035 GUIDE WIRE