BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3073168 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02463
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-02462. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING BIFURCATED IN 3 ARTERY. THE 2.0 X 8MM NC QUANTUM APEX MR BALLOON CATHETER WAS INFLATED AND RUPTURED AT 10ATMS. THIS WAS EXCHANGED WITH ANOTHER 2.0 X 8MM NC QUANTUM APEX MR BALLOON CATHETER, WAS INFLATED AT 10ATMS, AND RUPTURED . THIS WAS REPLACED WITH A 2.5 X 10MM FLEXTOME CB MR BALLOON CATHETER, INFLATED AT 6ATMS, AND RUPTURED. THEY DID NOT COMPLETE THE PROCEDURE AT THIS TIME AS THEY NOTED THAT A ROTATIONAL ATHERECTOMY PROCEDURE WAS NEEDED FOR THE TREATMENT OF THIS LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174847 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408200 15324711

    Patients

    Seq Age Sex Outcome Treatment
    1