QUANTUM MAVERICK MONORAIL

Additional Manufacturer Narrative

RETURNED PRODUCT ANALYSIS VERIFIED THE DIFFICULTY STATED IN THE COMPLAINT. PRODUCT ANALYSIS ALSO REVEALED A SHAFT KINK. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS RECEIVED AND SHAFT KINK WAS OBSERVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A TEAR IN THE BALLOON WALL LOCATED 1.7 CENTIMETERS PROXIMALLY FROM THE DISTAL TIP. THE CATHETER ALSO EXHIBITED A KINK IN THE SHAFT LOCATED 51.8 CENTIMETERS DISTALLY FROM THE EDGE OF THE STRAIN RELIEF. VISUAL AND MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 7511497 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE INFLATION DIFFICULTIES AND SHAFT KINK COULD NOT BE DETERMINED.

Description of Event or Problem

DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON 9/20/06. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED AND CALCIFIED LESION WAS LOCATED IN THE NON-TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE QUANTUM MAVERICK BALLOON EXPERIENCE REDUCED PRESSURE DURING INFLATION. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE NOTED. PT STATUS IS REPORTED AS "GOOD".