BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1080621 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02022
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC AND CALCIFIED LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED; THE BALLOON RUPTURED AT 18 ATMOSPHERES OF PRESSURE (ATM'S). THE NUMBER OF INFLATIONS AND TO WHAT (ATM'S) IS UNKNOWN. THE BALLOON WAS USED FOR BOTH PRE AND POST DILATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 12X3.0 MM 11512367

    Patients

    Seq Age Sex Outcome Treatment
    1