BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?

    MDR report key: 4242394 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-07131
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    IT WAS REPORTED THAT THE DISTAL END OF THE COIL WAS BROKEN. A 6MM X 10CM INTERLOCK¿ WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION LOCATED IN THE MODERATELY TORTUOUS SPLENIC ARTERY. DURING PROCEDURE, CONTINUOUS FLUSH WAS PERFORMED, THE INTRODUCER SHEATH WAS CONNECTED TOWARDS THE HUB OF THE RENEGADE MICROCATHETER. RESISTANCE WAS FELT UPON ADVANCING THE COIL INTO THE HUB OF THE CATHETER. THE PHYSICIAN THEN PUSHED AND PULLED THE COIL SEVERAL TIMES. AS A RESULT, THE DISTAL END OF THE COIL WAS BROKEN. THE COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE COIL WAS BENT. THE COIL AND THE PUSHER WIRE ARMS WERE INTERLOCKED IN THE INTRODUCER SHEATH AND THE ROTATING HEMOSTATIC VALVE WAS NOT OVERTIGHTENED. THE DELIVERY WIRE WAS NOT ROTATED MORE THAN 360 DEGREES DURING THE DELIVERY OF THE DEVICE AND THE TWIST LOCK WAS FULLY OPENED. FURTHERMORE, THE PROCEDURE WAS COMPLETED WITH THE SAME MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726914 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361560 16538631

    Patients

    Seq Age Sex Outcome Treatment
    1 COILS: INTERLOCK¿DELTAMAXX| MICRO CATHETER: RENEGADE 2M