BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1060152 · Received June 11, 2008

    Report

    Report Number
    2953148-2008-00600
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING HEARTSTRING SEAL HS-1045, THREE SEALS DID NOT DEPLOY AND ONE SEAL UNRAVELED AFTER DEPLOYMENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL. THIS REPORT IS FOR THE THIRD SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-1045 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA