BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-33-QL-PFO

    MDR report key: 477491 · Received August 8, 2003

    Report

    Report Number
    1222632-2003-00014
    Event Type
    Injury
    Date Received
    August 8, 2003
    Date of Event
    July 9, 2003
    Report Date
    August 8, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTING PHYSICIAN REPORTED THAT DURING A PFO CLOSURE THE CARDIOSEAL IMPLANT BECAME DETACHED FROM THE DELIVERY SYSTEM. THE DEVICE WAS SNARED AND RETRACTED TO THE RIGHT FEMORAL VEIN AND SURGICALLY REMOVED. PATIENT IS FINE POST SURGERY. IMPLANT AND DELIVERY SYSTEM WILL NOT BE RETURNED. THE PHYSICIAN EXPRESSED CONCERN AS TO WHETHER OR NOT THE IMPLANT WAS PROPERLY CONNECTED TO THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-33-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-33-QL-PFO 0305233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention