BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 3182196 · Received June 21, 2013

    Report

    Report Number
    1226348-2013-20117
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A DELTAPAQ PLATINUM MICROCOIL 5 MM X 10 CM (DFS10051020/C12749) STRETCHED DURING MANIPULATION OF COIL IN MICROCATHETER DURING A CASE. NO OTHER DETAILED INFORMATION REGARDING PATIENT OUTCOME, ANEURYSM LOCATION, TARGET VESSEL CHARACTERISTICS, OR CONCOMITANT DEVICES WAS MADE AVAILABLE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. BASED ON THE LIMITED INFORMATION PROVIDED, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    DELTAPAQ PLATINUM MICROCOIL 5 MM X 10 CM ((B)(4)) STRETCHED DURING MANIPULATION OF COIL IN MICROCATHETER DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282123 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C12749

    Patients

    Seq Age Sex Outcome Treatment
    1 - MICROCATHETER (DETAILS UNKNOWN)