BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK¿-35

    MDR report key: 2970364 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-01222
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED AS THE BATCH NUMBER WAS UNKNOWN. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DFU STATES: "THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY THROUGH A 5F (0.035 IN [0.89 MM] OR 0.038 IN [0.97 MM] INNER LUMEN) IMAGER II DIAGNOSTIC CATHETER". "THE USE OF OTHER DIAGNOSTIC CATHETERS MAY RESULT IN AN INABILITY TO DELIVER, DEPLOY OR RECAPTURE THE DEVICE". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL WAS STUCK IN THE CATHETER, POSSIBLY PROTRUDING FROM THE DISTAL END. THE PATIENT WAS UNDERGOING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). PRIOR TO THE PLACEMENT OF THE STENT GRAFT, THE PHYSICIAN PLANNED TO IMPLANT COILS FOR ENDO LEAK PREVENTION. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS INTERNAL ILIAC ARTERY. A .038 5FR NON BSC CATHETER WAS POSITIONED INSIDE THE PATIENT. TWO NON BSC COILS WERE IMPLANTED. THE 12 MM X 20 CM INTERLOCK -35 COIL WAS THEN ADVANCED IN THE CATHETER, BUT SEEMED TO GET STUCK. THE PHYSICIAN WAS UNABLE TO REMOVE IT, EVEN AFTER APPLYING FORCE. AS THE PHYSICIAN WASN'T SURE EXACTLY WHERE IN THE CATHETER THE COIL WAS STUCK, HE ADVANCED A BENTSON WIRE TO TRY AND PUSH THE COIL OUT OF THE DISTAL END, BUT WAS NOT SUCCESSFUL. THE COIL WAS ABLE TO BE PUSHED OUT BY FLUSHING THE CATHETER WITH SALINE. THE COIL WAS IMPLANTED, BUT WAS STRETCHED. A STENT GRAFT WAS SUCCESSFULLY PLACED OVER THE COILS, AS INTENDED, TO COMPLETE THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73551 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention