BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?

    MDR report key: 3971688 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04424
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    February 18, 2014
    Report Date
    July 8, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. A COIL AND ROTATING HEMOSTATIC VALVE WERE RETURNED. THE PUSHER WIRE AND THE INTERLOCKING ARM OF THE COIL WAS NOT RETURNED. THE COIL WAS STRETCHED AND KINKED. THE COIL ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE DIMENSIONS WERE FOUND TO BE IN SPECIFICATION. THE NUMBER OF FIBER BUNDLES WAS BELOW THE ASSIGNED SPECIFICATION. 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 DFU STATES: INTERLOCK FIBERED IDC GIVES INSTRUCTIONS ON HOW TO PREVENT FRICTION FROM OCCURRING DURING THE PROCEDURE BY RECOMMENDING THE USE OF A MICRO CATHETER WITH AN INNER DIAMETER OF 0.021IN. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE COIL THROUGH THE CATHETER. A 6MM X 20CM INTERLOCK¿ WAS USED TO TREAT THE TARGET LESION LOCATED IN THE MODERATELY TORTUOUS PORTAL VEIN. DURING INTRODUCTION, A NON BSC CATHETER WAS ADVANCED TO THE TARGET SITE AND COIL EMBOLIZATION WAS THEN STARTED. CONTINUOUS FLUSHING WAS PERFORMED. UPON ADVANCING THE COIL THROUGH THE NON BSC CATHETER, SEVERE RESISTANCE WAS ENCOUNTERED NEAR THE HUB. THE COIL AND THE CATHETER WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE COIL WAS MISSING AND THE NUMBER OF FIBER BUNDLES WAS BELOW THE ASSIGNED SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448213 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361570 16602073

    Patients

    Seq Age Sex Outcome Treatment
    1 MICRO CATHETER: VIRTUS2M| GUIDE WIRE: CHIKAI