BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 1904528 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05207
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K040342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 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 TRENDIGN 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 PROCEDURE, A COIL DETACHED PREMATURELY. THE INTERLOCKING DETACHABLE COIL DETACHED PREMATURELY WHEN THE PHYSICIAN TRIED TO RECAPTURE IT IN ANOTHER MANUFACTURER'S CATHETER. THE COIL WAS REMOVED FROM THE PATIENT. AN UNKNOWN NUMBER OF COILS WERE SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK UNK539

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGREAT TERUMO CATHETER, 0.22