BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPAQ - CERECYTE MICROCOIL

    MDR report key: 4086725 · Received September 12, 2014

    Report

    Report Number
    1226348-2014-00568
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ULTIPAQ CERECYTE MICROCOIL 4 MM X 8 CM (CFS10040830/F65972) WOULD NOT DETACH WHEN NEEDED. THE TECH AND PHYSICIAN CONFIRMED THAT AN APPROPRIATE PRE-TEST WAS COMPLETED. WHEN THE COIL WAS PLACED AND READY TO DETACH THE COIL WOULD NOT DETACH. NO FAULT LIGHTS WERE PRESENT ON THE ECB. IT SHOULD ALSO BE NOTED; THAT THE GREEN LIGHT WAS NOT ON WHEN THE DETACH WAS ATTEMPTED. SEVERAL ATTEMPTS WERE TRIED WITHOUT SUCCESS. TWO MORE ECB CABLES (DETAILS UNKNOWN) WERE OPENED AND ATTEMPTED WITHOUT SUCCESS. THE COIL WAS SUCCESSFULLY REMOVED AND SET ASIDE FOR RETURN TO MICRUS. THERE WAS NO RESISTANCE FELT DURING DPU/COIL DEPLOYMENT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. IT IS UNKNOWN IF UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. THE AUDIBLE SIGNAL DID NOT BEEP. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING. THE MOST LIKELY ROOT CAUSE OF THE COIL¿S NONDETACHMENT WAS DUE TO A FRACTURE OF THE SOLDER JOINT LOCATED IN THE RESISTIVE HEATING COIL SECTION. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    THE ULTIPAQ CERECYTE MICROCOIL 4 MM X 8 CM (CFS10040830/F65972) WOULD NOT DETACH WHEN NEEDED. THE TECH AND PHYSICIAN CONFIRMED THAT AN APPROPRIATE PRE-TEST WAS COMPLETED. WHEN THE COIL WAS PLACED AND READY TO DETACH THE COIL WOULD NOT DETACH. NO FAULT LIGHTS WERE PRESENT ON THE ECB. IT SHOULD ALSO BE NOTED; THAT THE GREEN LIGHT WAS NOT ON WHEN THE DETACH WAS ATTEMPTED. SEVERAL ATTEMPTS WERE TRIED WITHOUT SUCCESS. TWO MORE ECB CABLES (DETAILS UNKNOWN) WERE OPENED AND ATTEMPTED WITHOUT SUCCESS. THE COIL WAS SUCCESSFULLY REMOVED AND SET ASIDE FOR RETURN TO MICRUS. THERE WAS NO RESISTANCE FELT DURING DPU/COIL DEPLOYMENT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. IT IS UNKNOWN IF UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. THE AUDIBLE SIGNAL DID NOT BEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564242 ULTIPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F65972

    Patients

    Seq Age Sex Outcome Treatment
    1 3 CABLES (DETAILS UNKNOWN)