BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 1891299 · Received November 4, 2010

    Report

    Report Number
    2134265-2010-05115
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K040342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 COIL EMBOLIZATION TREATMENT PROCEDURE THE COIL DETACHED. THE INTENDED LOCATION WAS THE INTERNAL ILIAC ARTERY. THE PHYSICIAN LOADED THE 8MM X 10CM INTERLOCKING DETACHABLE COIL INSIDE THE RENEGADE MICRO-CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO 'CONFIRM THE COIL' THE COIL WAS DETACHED. THE PHYSICIAN REMOVED THE COIL FROM THE RENEGADE AND DEPLOYED FOUR INTERLOCKING DETACHABLE COILS TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M0013608100 13374185

    Patients

    Seq Age Sex Outcome Treatment
    1 MICRO-CATHETER: RENEGADE 18 2M