BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2191341 · Received July 27, 2011

    Report

    Report Number
    2954740-2011-00031
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: SPH100500-20; LOT #: F67444, MFG DATE: 03/01/2011, EXP DATE: 03/31/2016; CATALOG #: SPH100620-20, LOT# F67734, MFG DATE: 03/01/2011, EXP DATE: 03/31/2016. THE PRODUCTS WERE NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICES, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MFG RECORDS FOR THESE LOT WERE REVIEWED AND DID NOR REVEAL ANY RELEVANT DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED N OTHER COMPLAINTS OF THIS TYPE WITH THE ABOVE LOTS.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: DURING COIL REPOSITIONING, ALL THREE (3) COILS STRETCHED WITH BALLOON (EV3) ASSISTED COILING. ADD'L INFO RECEIVED ON (B)(6) 2011 INDICATED THAT ALL THREE COILS WERE SUCCESSFULLY RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL INTERVENTION PERFORMED OR MEDICATION PRESCRIBED POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION F37385

    Patients

    Seq Age Sex Outcome Treatment
    1