BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?-35

    MDR report key: 4152789 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06534
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT:18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED A DELIVERY WIRE, INTRODUCER SHEATH AND A COIL WERE RETURNED. THE INTERLOCKING ARMS OF THE COIL AND DELIVERY WIRE WERE NOT INTERLOCKED. THE ZAP TIPS OF THE COILS WERE IN THE INTRODUCER SHEATH AND THE COIL WAS FULLY SHEATHED WITHIN THE INTRODUCER SHEATH. THE DELIVERY WIRE AND INTRODUCER SHEATH WERE NOTED TO BE KINKED. THE COIL COULD NOT BE ADVANCED OR RETRACTED FROM THE INTRODUCER SHEATH. THE INTRODUCER SHEATH HAD TO BE CUT TO FREE THE COIL. A MICROSCOPIC INSPECTION WAS PERFORMED. THE INTERLOCKING ARM OF THE DELIVERY WIRE WAS INSPECTED AND NO DAMAGE WAS NOTED. THE COIL IS STRETCHED AND KINKED. NO INTERLOCKING ARM WAS RETURNED. 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-06535. REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4)2014. IT WAS REPORTED THAT COIL COULD NOT BE PUSHED OUT FROM THE CATHETER. A 10MM X 40CM AND A 20MM X 40CM INTERLOCK¿-35 COILS WERE SELECTED FOR TREATMENT OF AN ANEURYSM IN THE RIGHT LOWER LIMB ARTERIOVENOUS FISTULA LUMEN PROSTHESIS. DURING THE PROCEDURE, NEITHER COIL COULD BE PUSHED OUT FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL WAS RETURNED WITHOUT ITS INTERLOCKING ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630724 INTERLOCK?-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001363830 0016440357

    Patients

    Seq Age Sex Outcome Treatment
    1