BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2496081 · Received March 8, 2012

    Report

    Report Number
    2954740-2012-00020
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES USED: COIL #2: CATALOG #: PC4100626-30; LOT# F60366; MFG DATE: 04/01/2010; EXP DATE: 04/30/2015. COIL 1 EVAL: THE COIL WAS RETURNED UNDAMAGED AND WAS STILL ATTACHED TO THE DEVICE POSITION UNIT (DPU) BY THE DETACHMENT FIBER. THE DETACHMENT FIBER IS INTACT AND UNDAMAGED. USING AN IN-HOUSE PROWLER LPES MICROCATHETER, THE RETURNED COIL WAS ADVANCED THROUGH AND OUT THE DISTAL TIP MULTIPLE TIMES WITH NO RESISTANCE ENCOUNTERED. AT NO TIME DID THE COIL BECOME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE ROOT CAUSE OF THE COIL BECOMING STUCK INSIDE THE MICROCATHETER CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE PROWLER LPES MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. COIL 2 EVAL: THE ENTIRE COIL WAS RETURNED SEVERELY DAMAGED FROM POST PROCEDURE HANDLING. BECAUSE OF THIS HANDLING ANY EVIDENCE FROM THE PROCEDURE HAS BEEN DESTROYED. DUE TO THE SEVERE DAMAGE TO THE COIL, NO LAB FUNCTIONAL TESTING WAS POSSIBLE. THE RETURNED COIL WAS STILL ATTACHED TO THE DEVICE POSITION UNIT (DPU) BY THE DETACHMENT FIBER. THE DETACHMENT FIBER IS INTACT AND UNDAMAGED. THE MICROCOIL SYSTEM WAS CLEANED BY THE END USER BEFORE BEING RETURNED. THEREFORE, THE ROOT CAUSE OF THE COIL BECOMING STUCK INSIDE THE MICROCATHETER FOLLOWED BY UNINTENDED DETACHMENT INSIDE THE MICROCATHETER CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE PROWLER LPES MICROCATHETER, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: TWO (2) DEVICES PREMATURELY DETACHED INSIDE THE MICROCATHETER DURING PROCEDURE WITH NO DETACHMENT ATTEMPTS. IT IS UNK WHY AND HOW IT OCCURRED. BOTH COILS WERE SAFELY RETRIEVED AND REPLACED WITH NEW ONES TO COMPLETE THE PROCEDURE WITH NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F60369

    Patients

    Seq Age Sex Outcome Treatment
    1