BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE 10 - CERECYTE MICROCOIL

    MDR report key: 4086645 · Received September 12, 2014

    Report

    Report Number
    1226348-2014-00560
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K0022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER 10 MINS OF TRYING TO PLACE THIS FIRST COIL MICRUSPHERE 10 CERECYTE MICROCOIL 2 MM X 2.5 CM (CSP10020030/F50577) IN A SHALLOW WIDE NECK ANEURYSM ¿ THE PRODUCT DID NOT DETACH. THE CONNECTING CABLE (F64019/CATALOG UNKNOWN) WAS CHANGED TO A NEW CONNECTING CABLE (DETAILS UNKNOWN) AND THREE DETACHMENT BOXES USED (DETAILS UNKNOWN). A PREVIOUSLY OPENED AND RETRIEVED MICRUSPHER 2.5 AND 3CM (DETAILS UNKNOWN) WAS REINTRODUCED AND SUCCESSFULLY DETACHED USING THE ORIGINAL DCB. THERE WAS NO RESISTANCE FELT DURING DPU/COIL DEPLOYMENT. AN SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED FOR THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT DID NOT ILLUMINATE. THE AUDIBLE SIGNAL DID NOT BEEP. THE COIL WAS REPOSITIONED ONCE IT WAS PLACED IN THE ANEURYSM. THE DETACHMENT BUTTON WAS PRESSED 3 TIMES FOR EACH BOX. THE COIL WAS SAFELY WITHDRAWN AFTER IT FAILED TO DETACH. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS ¿ 21 CFR PART 803, MEDICAL DEVICE REPORTING. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: CONNECTING CABLE (F64019/CATALOG UNKNOWN); NEW CONNECTING CABLE (DETAILS UNKNOWN); THREE DETACHMENT BOXES (DETAILS UNKNOWN); MICRUSPHER 2.5 AND 3CM (DETAILS UNKNOWN); SL-10 MICROCATHETER (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    AFTER 10 MINS OF TRYING TO PLACE THIS FIRST COIL MICRUSPHERE 10 CERECYTE MICROCOIL 2 MM X 2.5 CM (CSP10020030/F50577) IN A SHALLOW WIDE NECK ANEURYSM ¿ THE PRODUCT DID NOT DETACH. THE CONNECTING CABLE (F64019/CATALOG UNKNOWN) WAS CHANGED TO A NEW CONNECTING CABLE (DETAILS UNKNOWN) AND THREE DETACHMENT BOXES USED (DETAILS UNKNOWN). A PREVIOUSLY OPENED AND RETRIEVED MICRUSPHER 2.5 AND 3CM (DETAILS UNKNOWN) WAS REINTRODUCED AND SUCCESSFULLY DETACHED USING THE ORIGINAL DCB. THERE WAS NO RESISTANCE FELT DURING DPU/COIL DEPLOYMENT. AN SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED FOR THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT DID NOT ILLUMINATE. THE AUDIBLE SIGNAL DID NOT BEEP. THE COIL WAS REPOSITIONED ONCE IT WAS PLACED IN THE ANEURYSM. THE DETACHMENT BUTTON WAS PRESSED 3 TIMES FOR EACH BOX. THE COIL WAS SAFELY WITHDRAWN AFTER IT FAILED TO DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563892 MICRUSPHERE 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F50577

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR