FDA Adverse Event Malfunction Summary report: N

QUANTUM MAVERICK BALLOON CATHETER

MDR report key: 1801131 · Received August 16, 2010

Report

Report Number: 2134265-2010-03839
Event Type: Malfunction
Date Received: August 16, 2010
Date of Event: July 21, 2010
Report Date: July 21, 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

(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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). A 15MM X 3.0MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED AND INFLATED THREE TIMES TO 18 ATMS. ON THE FOURTH INFLATION THE BALLOON RUPTURED AT 18 ATMS. THE BALLOON CATHETER WAS SUCCESSFULLY REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT IS 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	H7493808015300	12915379

Patients

Seq	Age	Sex	Outcome	Treatment
1				STENT, PROMUS\| GUIDE CATHETER, 6F LAUNCHER\| GUIDE WIRE, RUNTHROUGH NS