BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK?-35

    MDR report key: 3192856 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04534
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: BORN IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. A COIL WAS RETURNED PROTRUDING DISTALLY FROM A CATHETER. THE HUB OF THE CATHETER WAS REMOVED AND THE CATHETER WAS HELD TOGETHER BY A TIE WRAP. THIS WAS REMOVED FOR ANALYSIS. THE COIL WAS ATTEMPTED TO BE PULLED THROUGH THE CATHETER BUT A RESISTANCE WAS MET. THE CATHETER HAD TO BE CUT IN AN ATTEMPT TO RETRIEVE THE COIL. A FIBER BUNDLE FELL OFF DURING THE RETRIEVAL OF THE COIL. THE COIL WAS FOUND TO BE STRETCHED AND SEVERELY KINKED DISTALLY IN THE REGION OF THE INTERLOCKING ARM OF THE COIL. THE COIL WAS ALSO FOUND TO BE KINKED DISTALLY FROM THE PROCEDURE. THE COIL WAS INADVERTENTLY KINKED IN AN ATTEMPT TO REMOVE IT FROM THE CATHETER. A MICROSCOPIC INSPECTION REVEALED THE COIL ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL WAS INSPECTED AND NO DAMAGE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER ERROR AS THE DFU STATES: ¿THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY THROUGH A 5F (1.70 MM) OD (0.035 IN [0.89 MM] OR 0.038 IN [0.97 MM] INNER LUMEN) 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VARICOCELE EMBOLIZATION TREATMENT PROCEDURE, PREMATURE COIL DETACHMENT OCCURRED. THE TARGET LESION IS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT SPERMATIC VEIN. THREE INTERLOCKING DETACHABLE COILS WERE SELECTED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, 8MM X 20 CM INTERLOCK-35 DETACHABLE COIL WAS DEPLOYED FIRST WITH NO ISSUE. THE SECOND COIL, 8MM X 20 CM INTERLOCK-35 DETACHABLE COIL , WAS THEN MOUNTED TO A NON-BSC MICROCATHETER. THE SECOND COIL INITIALLY FAILED TO DETACH FROM THE INTERLOCKING ARM MECHANISM. THE PHYSICIAN HAD TO MANIPULATE THE SYSTEM WITH SUBTLE MOVEMENTS TO DETACH THE COIL FROM THE INTERLOCKING ARM AND IT WAS DEPLOYED SUCCESSFULLY. THEN THE THIRD COIL, 10MM X 40 CM INTERLOCK-35 DETACHABLE COIL WAS INSERTED. WHEN THE COIL WAS ADVANCED THE INTERLOCKING ARMS DETACHED PREVENTING FURTHER PROGRESSION OF THE COIL. THE COIL PROTRUDED OUTSIDE THE MICROCATHETER WITH THE DISTAL COIL IN THE VEIN. THE PHYSICIAN HAD TO CUT THE HUB OF THE MICROCATHETER AND MOUNTED A 5FR INTRODUCER SHEATH TO FACILITATE THE REMOVAL OF THE MICROCATHETER TOGETHER WITH THE PROTRUDING COIL. THE COIL WAS REMOVED COMPLETELY FROM THE PATIENT. THE COIL WAS NOT BROKEN OR MIGRATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VARICOCELE EMBOLIZATION TREATMENT PROCEDURE, PREMATURE COIL DETACHMENT OCCURED. THE TARGET LESION IS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT SPERMATIC VEIN. THREE INTERLOCKING DETACHABLE COILS WERE SELECTED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, 8MM X 20 CM INTERLOCK-35 DETACHABLE COIL WAS DEPLOYED FIRST WITH NO ISSUE. THE SECOND COIL, 8MM X 20 CM INTERLOCK-35 DETACHABLE COIL , WAS THEN MOUNTED TO A NON-BSC MICROCATHETER. THE SECOND COIL INITIALLY FAILED TO DETACH FROM THE INTERLOCKING ARM MECHANISM. THE PHYSICIAN HAD TO MANIPULATE THE SYSTEM WITH SUBTLE MOVEMENTS TO DETACH THE COIL FROM THE INTERLOCKING ARM AND IT WAS DEPLOYED SUCCESSFULLY. THEN THE THIRD COIL, 10MM X 40 CM INTERLOCK-35 DETACHABLE COIL WAS INSERTED. WHEN THE COIL WAS ADVANCED THE INTERLOCKING ARMS DETACHED PREVENTING FURTHER PROGRESSION OF THE COIL. THE COIL PROTRUDED OUTSIDE THE MICROCATHETER WITH THE DISTAL COIL IN THE VEIN. THE PHYSICIAN HAD TO CUT THE HUB OF THE MICROCATHETER AND MOUNTED A 5FR INTRODUCER SHEATH TO FACILITATE THE REMOVAL OF THE MICROCATHETER TOGETHER WITH THE PROTRUDING COIL. THE COIL WAS REMOVED COMPLETELY FROM THE PATIENT. THE COIL WAS NOT BROKEN OR MIGRATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294099 INTERLOCK?-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001363610 0015488856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention