BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 837125 · Received February 20, 2007

    Report

    Report Number
    6000093-2007-00376
    Event Type
    Malfunction
    Date Received
    February 20, 2007
    Date of Event
    January 22, 2007
    Report Date
    January 22, 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

    PRODUCT ANALYSIS VERIFIED THE DIFFICULTY AS STATED IN THE COMPLAINT. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS REC'D IN GOOD CONDITION WITH NO DAMAGE OBSERVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A TEAR IN THE BALLOON WALL LOCATED 13 MILLIMETERS PROXIMALLY FROM THE DISTAL TIP. 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. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL OR WITH THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE EXACT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 7822844 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 BALLOON BURST DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE QUANTUM MAVERICK MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS LOCATED IN THE VERY TORTUOUS AND 99% STENOSED APICAL CORONARY ARTERY. THIS DEVICE WAS USED FOLLOWING ABLATION WITH A ROTABLATOR. THE QUANTUM MAVERICK MONORAIL BALLOON RUPTURED AT 18ATMS AT UNK INFLATIONS. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNK. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNK DEVICE, AND NO PT COMPLICATIONS WERE REPORTED. PT STATUS WAS REPORTED AS '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 12X2.75MM 7822844

    Patients

    Seq Age Sex Outcome Treatment
    1 *