BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 832144 · Received February 8, 2007

    Report

    Report Number
    6000093-2007-00282
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    January 8, 2007
    Report Date
    January 10, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT ANALYSIS VERIFIED THE DIFFICULTY 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 EXAMINATION OF THE BALLOON MATERIAL REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL. VISUAL AND MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE LONGITUDINAL 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 THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE TEAR. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 9211778 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. THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED AT 10 ATMS ON THE INITIAL INFLATION. THE LOCATION OF THE LESION BEING TREATED IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. PT STATUS IS REPORTED "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BOSTON SCIENTIFIC MAVERICK2 15/3.0 9211778

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR