FDA Adverse Event Malfunction Summary report: N

QUANTUM MAVERICK MONORAIL BALLOON CATHETER

MDR report key: 917667 · Received March 26, 2007

Report

Report Number: 6000093-2007-00633
Event Type: Malfunction
Date Received: March 26, 2007
Date of Event: February 27, 2007
Report Date: February 27, 2007
Manufacturer: BOSTON SCIENTIFIC
Product Code: LOX
PMA / PMN Number: p860019/s167
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8892146 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE QUANTUM MAVERICK MONORAIL BALLOON RUPTURED. THE 75% STENOSED LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00MM BALLOON WAS USED, BUT FAILED TO DILATE THE LESION. THE 3.00 BALLOON WAS REPLACED WITH THE QUANTUM MAVERICK MONORAIL CATHETER. THE QUANTUM MAVERICK MONORAIL BALLOON RUPTURED AT 20 ATMS ON THE INITIAL INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER QUANTUM MAVERICK MONORAIL CATHETER. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED "GOOD".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUANTUM MAVERICK MONORAIL BALLOON CATHETER	LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO	LOX	BOSTON SCIENTIFIC	12X3.0 MM	8892146

Patients

Seq	Age	Sex	Outcome	Treatment
1	*			6F RUNWAY JR4 GUIDE CATHETER\| RYUJIN BALLOON CATHETER\| PILOT GUIDE WIRE