BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?-35

    MDR report key: 3122178 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03502
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PREPARATION FOR AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL ARM DETACHED PREMATURELY. THE TARGET LOCATION WAS LOCATED IN THE HYPOGASTRIC ARTERY. WHILE PREPARING THE 15MM X 40CM .035 INTERLOCK CUBE, IT WAS NOTED THAT THE INTERLOCKING ARM DETACHED FROM PUSHER AND THE COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. AS THIS EVENT OCCURRED DURING PREPARATION OUTSIDE THE PATIENT, NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223758 INTERLOCK?-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363820 15551590

    Patients

    Seq Age Sex Outcome Treatment
    1