BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK¿-35

    MDR report key: 2962037 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00660
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED ONLY THE COIL WAS RETURNED. BLOOD WAS PRESENT ON THE FIBER BUNDLES. THE COIL WAS STRETCHED AND THE INTERLOCKING ARM WAS NOT PRESENT. MICROSCOPIC INSPECTION REVEALED THE COIL ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DFU STATES: -"THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY THROUGH A (B)(4) IMAGER II SELECTIVE DIAGNOSTIC CATHETER WITHOUT SIDE FLUSHING HOLES." -"THE USE OF OTHER DIAGNOSTIC CATHETERS MAY RESULT IN AN INABILITY TO DELIVER, DEPLOY, OR RECAPTURE THE DEVICE." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING TREATMENT OF A VARICOCELE. A 5FR C2 NON BSC CATHETER WAS POSITIONED IN THE PATIENT. TWO INTERLOCK COILS WERE DEPLOYED WITHOUT ISSUE. THE 10MM X 20CM .035 INTERLOCK DETACHABLE COIL WAS BEING DEPLOYED AT THE PROXIMAL AREA OF THE GONADAL VEIN. WHEN 90% OF THE COIL WAS DEPLOYED OUTSIDE OF THE CATHETER, THE PHYSICIAN DETERMINED IT WAS TOO LONG AND ATTEMPTED TO RETRACT IT; HOWEVER, THE COIL ELONGATED AND DETACHED FROM THE PUSHER WIRE END. THE PHYSICIAN NOTED THERE WAS NO RESISTANCE WHEN RETRACTING THE COIL, HE ONLY FELT A 'SLIGHT SNAP'. THEY ADVANCED ANOTHER WIRE THROUGH THE CATHETER AND TANGLED IT WITH THE COIL TO SECURE IT AND THEN PULLED THE CATHETER, WIRE AND COIL OUT TOGETHER. WHEN THE COIL WAS REMOVED, IT WAS OBSERVED TO BE STRETCHED AND THE INTERLOCKING ARM WAS MISSING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING TREATMENT OF A VARICOCELE. A 5FR C2 NON BSC CATHETER WAS POSITIONED IN THE PATIENT. TWO INTERLOCK COILS WERE DEPLOYED WITHOUT ISSUE. THE 10MM X 20CM .035 INTERLOCK DETACHABLE COIL WAS BEING DEPLOYED AT THE PROXIMAL AREA OF THE GONADAL VEIN. WHEN 90% OF THE COIL WAS DEPLOYED OUTSIDE OF THE CATHETER, THE PHYSICIAN DETERMINED IT WAS TOO LONG AND ATTEMPTED TO RETRACT IT; HOWEVER, THE COIL ELONGATED AND DETACHED FROM THE PUSHER WIRE END. THE PHYSICIAN NOTED THERE WAS NO RESISTANCE WHEN RETRACTING THE COIL, HE ONLY FELT A 'SLIGHT SNAP'. THEY ADVANCED ANOTHER WIRE THROUGH THE CATHETER AND TANGLED IT WITH THE COIL TO SECURE IT AND THEN PULLED THE CATHETER, WIRE AND COIL OUT TOGETHER. WHEN THE COIL WAS REMOVED, IT WAS OBSERVED TO BE STRETCHED AND THE INTERLOCKING ARM WAS MISSING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64681 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363600 15539154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention