FDA Adverse Event Malfunction Summary report: N

QUANTUM¿ MAVERICK¿

MDR report key: 3011116 · Received March 19, 2013

Report

Report Number: 2134265-2013-01472
Event Type: Malfunction
Date Received: March 19, 2013
Date of Event: February 19, 2013
Report Date: February 19, 2013
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

(B)(4). DEVICE EVALUATED BY MANUFACTURER: THE NC QUANTUM APEX CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL 5MM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A 2.5X20MM QUANTUM MAVERICK BALLOON WAS USED TO POST DILATE A 2.5X33MM NON-BSC STENT, HOWEVER THE BALLOON RUPTURED AT THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114108	QUANTUM¿ MAVERICK¿	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493808020250	15241369

Patients

Seq	Age	Sex	Outcome	Treatment
1				2.5X33MM XIENCE STENT