BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2093896 · Received April 19, 2011

    Report

    Report Number
    2954740-2011-00022
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ONLY THE DEVICE POSITIONING UNIT (DPU) WAS RETURNED. THE COIL AND THE SL-10 MICROCATHETER WERE NOT INCLUDED IN THE RETURNED PACKAGE. OBSERVATION: UPON RECEIPT OF THE PRODUCT, VISUAL INSPECTION WAS PERFORMED. IT WAS OBSERVED THAT THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND DID NOT MELT. CONCLUSION: DURING REPOSITIONING AND WHEN THE COIL WAS RETRACTED, THE MICROCATHETER MOVED AWAY FROM THE ANEURYSM. AT THIS POINT, THE COIL UNINTENTIONALLY DETACHED FROM THE DPU. THE EVIDENCE SUGGESTED THAT THE COIL ANCHORED IN THE COIL MASS DURING RETRIEVAL. THE CIRCUMSTANCES OF HOW AND WHERE THE COIL BECAME ANCHORED CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE SL-10 MICROCATHETER AND THE COIL USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED 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

    NOTE: AFTER CAREFUL REVIEW, THIS COMPLAINT WAS DECIDED UPON TO BE A REPORTABLE EVENT. PER RECEIVED REPORT: AS THE COIL WAS DEPLOYED IN THE ANEURYSM, ON LOOP COULD NOT BE POSITIONED SO THE ENTIRE COIL WAS PULLED BACK. DURING RETRIEVAL, THE MICROCATHETER SLID OFF THE ANEURYSM AND THE ENTIRE COIL MIGRATED OUT OF THE VESSEL. AS THE COIL WAS BEING PULLED BACK, THE COIL UNINTENTIONALLY DETACHED AND GOT ENTANGLED WITH THE MATRIX COIL WHICH ALSO CAME OUT OF THE ANEURYSM. THE DELTAPUSH COIL WAS SAFELY RETRIEVED BY A SNARE CATHETER. THE RETRIEVED COIL WAS EXAMINED AND SHOWED NO SIGN OF UNRAVELING. ADD'L INFO RECEIVED ON 1/31/2011 INDICATED THAT THE PROCEDURE FINISHED WITH NO PROBLEMS, THE PT WAS REPORTED FINE AND NO ADD'L MEDICATIONS ADMINISTERED POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION G12221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention