BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿ FLEX

    MDR report key: 2871804 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07549
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: 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 INTERVENTION PROCEDURE, A SHAFT FRACTURE OCCURRED. AS THE 1.5 X 20 MM APEX FLEX MR BALLOON CATHETER WAS BEING INSERTED INTO THE Y CONNECTOR TOO QUICKLY THE SHAFT KINKED AND FRACTURED IN THE MID SECTION, BUT STAYED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX¿ FLEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895920150

    Patients

    Seq Age Sex Outcome Treatment
    1