BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPAQ - CERECYTE MICROCOIL

    MDR report key: 4060193 · Received September 4, 2014

    Report

    Report Number
    1226348-2014-00344
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMPLAINT CONCLUSION: THE DEVICE WAS RETURNED FOR ANALYSIS. NO KINKS WERE FOUND ON THE HYPOTUBE SECTION OF THE DEVICE POSITIONING UNIT (DPU). LOCATED 28CM PROXIMALLY OF THE DISTAL TIP OF THE GREEN INTRODUCER, THE PROXIMAL END OF THE COIL HAD PROTRUDED OUTSIDE THE SHEATH. AS VIEWED THROUGH THE SHEATH AND LOCATED DISTALLY OFF THE PROXIMAL END OF THE COIL FOR A LENGTH OF 1.6CM IS SEVERE COIL DAMAGED WITH MULTIPLE SECTIONS OF BUCKLING AND COMPRESSION. THE PROXIMAL END OF THE COIL HAS SEVERE COMPRESSION AND BUCKLING DAMAGE. THE EVIDENCE SUGGESTS THAT DISTAL INTERFERENCE BETWEEN THE HEMOSTATIC VALVE AND INSIDE THE MICROCATHETER TUBING MOST LIKELY CAUSED THE COIL TO BECOME STUCK. THE EXACT SOURCE AND LOCATION OF THIS INTERFERENCE CANNOT BE DETERMINED. THEREFORE, TWO CONTRIBUTING FACTORS WERE FOUND THAT MAY HAVE LED TO THE COIL BECOMING STUCK. THE FIRST FACTOR IS THE SELECTION OF AN INCOMPATIBLE SERIES 18 MICROCATHETER THAT WAS USED WITH A 10 SERIES MICROCOIL SYSTEM. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL DAMAGE; THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS: ¿THE MICRUS MICROCOIL 10 SYSTEM IS COMPATIBLE WITH MICROCATHETERS WITH INNER LUMEN DIAMETERS RANGING FROM 0.014 TO 0.017 IN (0.356 TO 0.432 MM).¿ THE EXCELSIOR 1018 MICROCATHETER HAS AN INNER LUMEN OF 0.019¿. THE SECOND CONTRIBUTING FACTOR WAS FROM THE TYPE OF PROXIMAL DAMAGE TO THE COIL AND THE LOCATION WHERE THE COIL BECAME KINKED. THE EVENT DESCRIPTION STATES THAT THE COIL BECAME KINKED BETWEEN THE HEMOSTATIC VALVE AND THE MICROCATHETER HUB. FOR OPTIMUM PRODUCT PERFORMANCE AND TOP PREVENT POTENTIAL DAMAGE; THE IFU RECOMMENDS: ¿¿ ADDITIONALLY, IF THE INTRODUCER TIP AND MICROCATHETER HUB ARE MISALIGNED; DAMAGE MAY OCCUR TO THE MICROCOIL AS IT PASSES THROUGH THIS TRANSITION.¿ SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE COMPLAINT, NO CORRECTIVE ACTIONS WERE TAKEN.

    Description of Event or Problem · 1

    THE COIL GOT STUCK AT THE CONNECTION BETWEEN THE EXCELSIOR 1018 MICROCATHETER AND Y-CONNECTOR. WHEN THE DELIVERY WIRE WAS PUSHED; IT GOT KINKED AND THE COIL HAD TO BE RETRIEVED. DURING PRODUCT ANALYSIS, IT WAS DETERMINED THAT THE COIL WAS DAMAGED. OTHER COILS WERE DEPLOYED BEFORE AND AFTER THIS COIL WITH NO PROBLEMS. THERE WAS NO SERIOUS INJURY OR REQUIRED INTERVENTION REQUIRED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540255 ULTIPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F45079

    Patients

    Seq Age Sex Outcome Treatment
    1