BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2073677 · Received April 13, 2011

    Report

    Report Number
    2954740-2011-00011
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K091504
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE PRODUCT, VISUAL AND FUNCTIONAL EXAMINATION WAS PERFORMED. ONLY THE DEVICE POSITIONING UNIT (DPU) WAS RECEIVED WITH TWO UNK CONNECTING CABLES IN THE PACKAGE. IT WAS OBSERVED THAT THE DETACHMENT FIBER RECEIVED HEAT WHICH THEN MELTED AND POOLED AROUND AND ABOVE THE DETACHMENT ZONE. THE MOST LIKELY ROOT CAUSE OF THE COIL FAILING TO DETACH AFTER 15 DETACHMENT ATTEMPTS AND THEN HAVING TO BE MECHANICALLY DETACHED WAS DUE TO THE MELTING DETACHMENT FIBER POOLING AROUND AND ABOVE THE DETACHMENT ZONE. THIS TEMPORARILY CAPTURED THE COIL UNTIL IT WAS RELEASED THROUGH MECHANICAL FORCE. THE TWO RETURNED CONNECTING CABLES PASSED ELECTRICAL AND FUNCTIONALITY TESTING. THEREFORE, IT IS HIGHLY UNLIKELY THAT THESE CONNECTING CABLES CONTRIBUTED TO THE COMPLAINT EVENT. IN ADDITION, WITHOUT THE RETURN OF THE DETACHMENT CONTROL BOX (DCB) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED NO OTHER COMPLAINTS OF THIS TYPE WITH THIS LOT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: THE REPORTED DEVICE WAS THE FIRST COIL USED IN THE TREATMENT OF AN ACUTE RUPTURED ANEURYSM. DESPITE NUMEROUS ATTEMPTS TO DETACH THE COIL, DETACHMENT WAS UNSUCCESSFUL AND HAD TO BE MECHANICALLY WITHDRAWN. AS THE COIL EVENTUALLY DETACHED, PART OF THE COIL WAS LEFT INSIDE THE MICROCATHETER. A SECOND PRESIDIO COIL WAS USED TO ADVANCE THE TAIL OF THE PREVIOUS COIL SUCCESSFULLY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION F62054

    Patients

    Seq Age Sex Outcome Treatment
    1