FDA Adverse Event Malfunction Summary report: N

STERLING ES PTA BALLOON DILATATION CATHETER

MDR report key: 1781203 · Received August 3, 2010

Report

Report Number: 2134265-2010-03269
Event Type: Malfunction
Date Received: August 3, 2010
Date of Event: July 6, 2010
Report Date: July 7, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LIT
PMA / PMN Number: K080982
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): 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 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 FACTORS. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). THE 1.5MM X 20MM STERLING ES PTA BALLOON DILATATION CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; THE BALLOON WAS INFLATED TO 8ATMS IN THE FIRST INFLATION AND 12ATMS FOR THE SECOND INFLATION. THE BALLOON RUPTURED AT 12ATMS ON THE THIRD INFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STERLING ES PTA BALLOON DILATATION CATHETER	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - MAPLE GROVE	H74939134152010	13432008

Patients

Seq	Age	Sex	Outcome	Treatment
1				STENT: LUMINEX\| GUIDE WIRE: CRUISE\| INTRODUCER SHEATH: DESTINATION