FDA Adverse Event Malfunction Summary report: N

QUANTUM MAVERICK BALLOON CATHETER

MDR report key: 1781202 · Received August 3, 2010

Report

Report Number: 2134265-2010-03223
Event Type: Malfunction
Date Received: August 3, 2010
Date of Event: July 2, 2010
Report Date: July 5, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
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 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 INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 12X2.0MM QUANTUM MAVERICK BALLOON WAS ADVANCED TO THE LESION. AFTER THE FIRST INFLATION TO 20ATMS/15SECS THE STENOSIS WAS NOT SIGNIFICANTLY REDUCED. THE BALLOON WAS INFLATED AGAIN BUT AFTER FIVE SECONDS INTO THE SECOND INFLATION THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CURRENT CONDITION IS LISTED AS "GOOD".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUANTUM MAVERICK BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493808012200	12125772

Patients

Seq	Age	Sex	Outcome	Treatment
1