BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?-35

    MDR report key: 4215204 · Received October 30, 2014

    Report

    Report Number
    2134265-2014-06970
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE INFORMATION RECEIVED STATES INTERMITTENT FLUSH WAS PERFORMED AND A NON-BSC DIAGNOSTIC CATHETER WAS USED. THE DFU INSTRUCTS THE USER TO BEGIN CONTINUOUS FLUSH BEFORE INTRODUCING THE COIL INTO THE CATHETER. THE DFU ALSO STATES THAT: ¿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.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS EXTENDING OUT OF THE CATHETER AND THE INTERLOCKING ARM OF THE COIL WAS DETACHED. THE TARGET AREA WAS AN ANEURYSMAL SEGMENT IN A MODERATE TO SEVERELY TORTUOUS SPLENIC ARTERY. A 8MM X 40CM INTERLOCK¿-35 WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. DURING PROCEDURE, THE COIL WAS UNABLE TO ADVANCE COMPLETELY TO A NON BSC DIAGNOSTIC CATHETER. INTERMITTENT FLUSHING WAS PERFORMED. UPON PULLING THE PUSHER WIRE OUT, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE CATHETER WITH PART OF IT EXTENDING ON THE TIP OF THE CATHETER TO THE MAIN VESSEL. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL INTO THE BODY WITH OTHER WIRES IN THE BACK END OF THE ADVANCER WIRE BUT FAILED. THE PHYSICIAN THEN REMOVED THE CATHETER WITH NO INCIDENT. HOWEVER, THEY DID NOTICED THAT THE INTERLOCKING ARM OF THE COIL DETACHED INSIDE THE DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695833 INTERLOCK?-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001363590 16556339

    Patients

    Seq Age Sex Outcome Treatment
    1