BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?

    MDR report key: 3914181 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03860
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    February 28, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. A PUSHER WIRE WAS RETURNED INSIDE AN INTRODUCER SHEATH. THE PUSHER WIRE WAS FOUND KINKED AND MAIN COIL WAS FOUND SEVERELY STRETCHED AND KINKED UPON INSPECTION. THERE WERE ONLY 17 FIBRE BUNDLES PRESENT WHICH WAS BELOW THE ASSIGNED SPECIFICATION. THE INTERLOCKING ARM OF THE PUSHER WIRE AND MAIN COIL WAS INSPECTED AND NO DAMAGE WAS NOTED. THE COIL ZAP TIP WAS INSPECTED AND DAMAGE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT INCORRECT PLACEMENT AND COIL RESISTANCE OCCURRED. A 2/5MM X 5.8CM INTERLOCK WAS SELECTED AND ADVANCED TO TREAT THE MODERATELY TORTUOUS ABDOMINAL AORTIC ANEURYSM. DURING PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE COIL. HOWEVER, THE COIL WAS NOT PLACED ON THE RIGHT LOCATION. THE PHYSICIAN RECAPTURE THE DEVICE BUT RESISTANCE WAS ENCOUNTERED. THE COIL WAS RE-SHEATHED INTO THE CATHETER AND WAS COMPLETELY REMOVED FROM THE PATIENT¿S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIBER BUNDLES WAS BELOW THE ASSIGNED SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391036 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361760 15780906

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR