BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK?

    MDR report key: 3781647 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02573
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED. A POUCH AND COIL FRAGMENT WERE RETURNED. A MAGNETIC CHECK WAS PERFORMED USING MAGNETIC PEN AND REVEALED THAT THE RETURNED FRAGMENT WAS NOT PART OF THE PUSHERWIRE BUT A SECTION OF A MAIN COIL. THE COIL FRAGMENT HAD ONE FIBER BUNDLE. THE COIL FRAGMENT WAS FOUND TO BE STRETCHED AND KINKED. A MICROSCOPIC INSPECTION REVEALED THAT THERE WAS NO ZAP TIP OR INTERLOCKING ARM PRESENT ON THE COIL FRAGMENT. NO MEASUREMENTS COULD BE TAKEN DUE TO THE RETURNED FRAGMENT BEING SO STRETCHED. THE PUSHER WIRE WAS NOT RETURNED. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUSHER WIRE BREAK OCCURRED. THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE FOR TREATMENT OF AN ANEURYSM LOCATED AT THE RENAL ARTERY. AFTER 9 INTERLOCK COILS WERE DEPLOYED, THIS 8MM X 20CM INTERLOCK COIL WAS SELECTED AND ADVANCED OUT OF THE RENEGADE MICROCATHETER, BUT THEY WERE UNABLE TO DEPLOY IT AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL INTO THE CATHETER. A SEPARATE COIL PUSHER WAS THEN USED TO AID IN DEPLOYMENT. AFTER SOME PUSHING, THE PUSHER WIRE OF THE INTERLOCK COIL BROKE PROXIMAL TO THE INTERLOCKING ARMS WHICH WERE STILL INTERLOCKED. THE COIL WAS THEN IMPLANTED AND IS CONTAINED WITHIN THE ANEURYSM; HOWEVER, THE PUSHER WIRE REMAINS OUTSIDE THE ANEURYSM. THE PROCEDURE WAS COMPLETED AND TREATMENT OF THE ANEURYSM WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUSHER WIRE BREAK OCCURRED. THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE FOR TREATMENT OF AN ANEURYSM LOCATED AT THE RENAL ARTERY. AFTER 9 INTERLOCK COILS WERE DEPLOYED, THIS 8MM X 20CM INTERLOCK COIL WAS SELECTED AND ADVANCED OUT OF THE RENEGADE MICROCATHETER, BUT THEY WERE UNABLE TO DEPLOY IT AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL INTO THE CATHETER. A SEPARATE COIL PUSHER WAS THEN USED TO AID IN DEPLOYMENT. AFTER SOME PUSHING, THE PUSHER WIRE OF THE INTERLOCK COIL BROKE PROXIMAL TO THE INTERLOCKING ARMS WHICH WERE STILL INTERLOCKED. THE COIL WAS THEN IMPLANTED AND IS CONTAINED WITHIN THE ANEURYSM; HOWEVER, THE PUSHER WIRE REMAINS OUTSIDE THE ANEURYSM. THE PROCEDURE WAS COMPLETED AND TREATMENT OF THE ANEURYSM WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260518 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361580 16154805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RENEGADE CATHETER| COIL PUSHER-16