BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 1014819 · Received March 17, 2008

    Report

    Report Number
    9610978-2008-00071
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY WITH LOT NUMBER 0410050902 AND 0411050490. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED AFTER A SUCCESSFUL STENT DEPLOYMENT, THERE WAS WITHDRAWAL DIFFICULTY OF THE STENT DELIVERY SYSTEM (SDS) THROUGH THE 6F CATHETER SHEATH INTRODUCER (CSI). THEREFORE, THE SDS SYSTEM WAS REMOVED WITH THE CSI AS ONE UNIT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS - FGE FGE CORDIS EUROPA, N.V. NA R1105855

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 6F SHEATH INTRODUCER