BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2443935 · Received February 7, 2012

    Report

    Report Number
    2954740-2012-00006
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST LIKELY ROOT CAUSE OF THE COILS UNINTENDED DETACHMENT OCCURRED DURING THE REPOSITIONING OF THE COIL INSIDE THE ANEURYSM. THE COIL BECAME ANCHORED TO EITHER THE COIL MASS AS REPORTED OR ON THE DISTAL TIP OF THE PRESHAPED MICROCATHETER. THE SEVERE DAMAGE AND THE SEVERING OF THE COIL OUT OF THE SOLDERED SECTION SUGGESTS THAT EXCESSIVE FORCE WAS USED DURING THE RETRACTION OF THE COIL. FOR OPTIMUM PRODUCT PERFORMANCE, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, "CAUTION: IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. CAUTION: IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER." IN ADDITION, WITHOUT THE RETURN OF THE PRESHAPED SL-10 MICROCATHETER AND THE SEVERED COIL USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD AN ADD'L CONTRIBUTION TO THE COMPLAINT EVENT. THE MFG 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: DURING PROCEDURE, RESISTANCE WAS ENCOUNTERED. AS THE PHYSICIAN TRIED TO PLACE THE COIL, IT BECAME ENTANGLED IN THE COIL MASS AND DETACHED UNINTENTIONALLY IN THE ANEURYSM. APPROX 5MM OF THE DISTAL END OF THE COIL REMAINED OUTSIDE THE ANEURYSM. THE PHYSICIAN SAFELY RETRIEVED THE COIL AND ITS ENTIRETY. A BALLOON CATHETER WAS PLACED TO PUSH THE REMAINING COIL IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED 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 G13886

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention