BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿-35

    MDR report key: 6852420 · Received September 8, 2017

    Report

    Report Number
    2134265-2017-08788
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    June 30, 2017
    Report Date
    August 17, 2017
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. A NON BSC 5F .038 CATHETER, AN RHV VALVE, A DELIVERY WIRE, AND COIL WERE RETURNED FOR THIS COMPLAINT. THE COIL AND DELIVERY WIRE ARMS WERE NOT INTERLOCKED WITHIN INTRODUCER SHEATH AS THE INTRODUCER SHEATH WAS NOT RETURNED. THE DISTAL END OF THE COIL WAS PROTRUDING FROM THE TIP OF THE NON BSC CATHETER. RESIDUES OF BLOOD WERE NOTED WITHIN THE RHV VALVE AND FIBERS OF THE COIL. THE COIL WAS ADVANCED WITH FRICTION FROM THE NON BSC CATHETER. THE DELIVERY WIRE WAS RETURNED DAMAGED NEAR THE INTERLOCKING ARM SINCE THE INNER WIRE IS NOT COVERED BY THE GREEN COVER. THE INTERLOCKING ARM WAS FOUND DETACHED FROM THE REST OF THE COIL. THE COIL WAS RETURNED STRETCHED WHERE THE INTERLOCKING ARM IS SUPPOSED TO BE. THE ZAP TIP SURFACE OF BOTH THE DELIVERY WIRE AND MAIN COIL WERE SMOOTH AND NO ISSUES WERE NOTED ON THE INTERLOCKING ARMS OF BOTH COMPONENTS. ALL DIMENSIONS THAT COULD BE MEASURED FOR BOTH THE DELIVERY WIRE AND MAIN COIL WERE WITHIN SPECIFICATIONS. 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: "IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM AND REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT THE 5F IMAGER II SELECTIVE DIAGNOSTIC CATHETER IS FLUSHED VIGOROUSLY, EITHER UTILIZING A CONTINUOUS FLUSH OR HAND INJECTION SETUP, BEFORE AND AFTER THE INTRODUCTION OF EACH INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM." ALSO STATES: "DO NOT ROTATE THE DELIVERY WIRE MORE THAN ONE TURN (360 DEGREES) DURING DELIVERY OF THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM. EXCESSIVE ROTATION OF THE DELIVERY WIRE MAY DAMAGE THE INTERLOCK¿ - 35 FIBERED IDC¿ OCCLUSION SYSTEM OR MAY RESULT IN PREMATURE DETACHMENT OF THE INTERLOCKING ARMS WITHIN THE CATHETER." (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-AUG-2017 IT WAS REPORTED THAT THE COIL BECAME STUCK INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT FEMORAL ARTERIOVENOUS MALFORMATION(AVM). A 20MM X 40CM INTERLOCK¿-35 WAS SELECTED FOR EMBOLIZATION. A 7F SHEATH WAS INSERTED ON THE LEFT INGUINAL ARTERY AND BLOOD FLOW WAS CONTROLLED WITH A 6F NON BSC BALLOON CATHETER. ANGIOGRAPHY WAS DONE AND A PUNCTURE WAS MADE DIRECTLY IN THE AVM FROM THE FEMORAL PART AND A 5FR SUPERSHEATH WAS INSERTED. DURING PROCEDURE, IT WAS NOTED THAT THE A INTERLOCK35 COIL BECAME STUCK INSIDE THE CATHETER. AN ATTEMPT TO PUSH THE COIL FORCIBLY; HOWEVER THE COIL DID NOT MOVE. THE COIL WAS THEN PULLED OUT; HOWEVER, THE COIL DETACHED INSIDE THE CATHETER AND WAS THEN REMOVED TOGETHER. THE CATHETER WAS THEN REPLACED WITH A NON BSC ANGIOGRAPHIC CATHETER. IT WAS FURTHER NOTED THAT THE INSERTION ANGLE OF THE SHEATH WAS STEEP BUT THE ANGIOGRAPHIC CATHETER WAS ABLE TO PUSH AND PULL. THE ANGIOGRAPHIC CATHETER WAS THEN NOTED TO HAVE ARCHED INSIDE THE AVM, THUS THE COMPLAINT DEVICE WAS THEN INSERTED; HOWEVER, THE COIL BECAME STUCK IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM OF THE COIL DETACHED AND THE DISTAL END OF THE COIL WAS PROTRUDING FROM THE TIP OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631136 INTERLOCK¿-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001363830 20298821

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: COOK BAL TYPE| INTRODUCER SHEATH: 5F MEDIKIT SUPER SHEATH