FDA Adverse Event Malfunction Summary report: N

STERLING ES PTA BALLOON DILATATION CATHETER

MDR report key: 2063388 · Received April 19, 2011

Report

Report Number: 2134265-2011-01309
Event Type: Malfunction
Date Received: April 19, 2011
Date of Event: March 28, 2011
Report Date: March 29, 2011
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 TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. ACCESS WAS GAINED THROUGH THE BRACHIAL ARTERY. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE 2MM X 20MM X 143CM STERLING ES MONORAIL BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WHEN THE BALLOON RUPTURED AT 4 ATM ON THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, FOLLOWED BY A STENT BEING PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT 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	H74939135202010	13001252

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDE WIRE: THRUWAY\| INTRODUCER SHEATH: BRITE TIP SHEATH 6F