BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿-35

    MDR report key: 3013314 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01702
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    SAME CASE AS MFR #: 2134265-2013-01703. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE CATHETER WAS REMOVED WITH THE COIL PROTRUDING FROM ITS TIP. THE PATIENT WAS UNDERGOING TREATMENT IN THE SPLENIC ARTERY. THE ANATOMY WAS NOTED TO BE "DIFFICULT" WITH A TORTUOUS VESSEL. UTILIZING CONTINUOUS FLUSH, A 5FR 035 NON BSC C2 CATHETER WAS POSITIONED IN THE VESSEL. AN 8MM X 20CM .035 INTERLOCK COIL WAS ADVANCED AND AFTER THE COIL WAS PARTIALLY DEPLOYED, IT BECAME STUCK IN THE TIP OF THE CATHETER. THE COIL AND CATHETER WERE REMOVED WITH THE COIL PROTRUDING FROM THE DISTAL END. THE SAME EVENT OCCURRED WITH THE NEXT 8MM X 20CM .035 INTERLOCK COIL. THE PROCEDURE WAS COMPLETED WITH NON BSC COILS, WITH DIFFICULTY NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115746 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363580

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK C2 .035 CATHETER