BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1180843 · Received September 23, 2008

    Report

    Report Number
    2134265-2008-02764
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE MODERATELY CALCIFIED 80% STENOTIC LESION WAS LOCATED IN THE MID-SEGMENT OF THE CIRCUMFLEX (CX) ARTERY. THE 2.5MM X 15 MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND REPORTED TO HAVE BURST AT 12 ATM'S WHEN INFLATED FOR 5 SECONDS. IT IS UNKNOWN HOW MANY TIMES OR ON WHICH INFLATION THE BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 15 / 2.5 11848520

    Patients

    Seq Age Sex Outcome Treatment
    1