BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE 18 - CERECYTE MICROCOIL

    MDR report key: 2801594 · Received October 23, 2012

    Report

    Report Number
    2954740-2012-00761
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K033813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT G13461 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NOTE: ADDITIONAL INFORMATION AND EVALUATION CODES WILL BE SUBMITTED WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED REPORTING THAT THE 4 MM X 7.9 CM MICRUSPHERE 18 CERECYTE MICROCOIL DETACHED WITHOUT ANYONE PRESSING THE DETACHMENT BUTTON PRIOR TO PROPER PLACEMENT AND DEPLOYMENT OF THE CASE. IT WAS INDICATED THAT THERE WAS NO PATIENT DEATH OR SERIOUS INJURY ALLEGED AS A RESULT OF THE EVENT AND NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS REQUIRED TO PREVENT IMPAIRMENT OR INJURY. THE PATIENT WAS STABLE DURING AND AFTER THE PROCEDURE. AN SL-10 (STRYKER) MICROCATHETER WAS USED WITH THE COIL SYSTEM. NO FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENT HAS BEEN PROVIDED IN RESPONSE TO INVESTIGATIONAL INQUIRIES. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE LIMITED INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED PREMATURE DEPLOYMENT OF THE COIL. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES USED: SL-10 STRYKER NEUROVASCULAR, NEURON .070 GUIDE, SYNCHRO 2 GUIDEWIRE, AND UNKNOWN MICRUS COILS- MULTIPLE. NOTE: THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT, THE DEVICE DETACHED WITHOUT ANYONE PRESSING THE DETACHMENT BUTTON PRIOR TO PROPER PLACEMENT AND DEPLOYMENT OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUSPHERE 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13461

    Patients

    Seq Age Sex Outcome Treatment
    1