BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPAQ - PLATINUM MICROCOIL

    MDR report key: 2890302 · Received December 29, 2012

    Report

    Report Number
    2954740-2012-00824
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE 2MMX 6 CM ULTIPAQ PLATINUM MICROCOIL COIL WOULD NOT DETACH ONCE DEPLOYED. IT WAS INDICATED THAT THERE WAS NO DEATH OR SERIOUS INJURY AS A RESULT OF THE EVENT AND NO ADDITIONAL MEDICAL INTERVENTION OR MEDICINE WAS REQUIRED TO PREVENT INJURY. IT WAS INITIALLY INDICATED THAT THE DEVICE WOULD BE RETURNED; HOWEVER, FOLLOW-UP INFORMATION REPORTED THAT WAS REPORTED THAT THE DEVICE WAS DISCARDED DUE TO THE PATIENT'S HEALTH STATUS. NO FURTHER PROCEDURAL INFORMATION IS AVAILABLE. BASED ON THE LACK OF INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS NO CONCLUSION CAN BE MADE REGARDING THE EVENT. 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.

    Description of Event or Problem · 1

    PER RECEIVED REPORT, THE COIL WOULD NOT DETACH ONCE DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F69861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER