BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX?

    MDR report key: 3132944 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03680
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. A 2.00MM X 15MM APEX BALLOON CATHETER WAS USED FOR POST DILATION AFTER PLACEMENT OF AN UNSPECIFIED PROMUS ELEMENT STENT. THE BALLOON RUPTURED ON FIRST INFLATION AT 14 ATMOSPHERES FOR 20 SECONDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234766 APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915200 14516304

    Patients

    Seq Age Sex Outcome Treatment
    1