BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1003543 · Received February 26, 2008

    Report

    Report Number
    2953148-2008-00202
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE THE HOSPITAL DISCARDED THE PRODUCT. SINCE THE PRODUCT WAS NOT RETURNED TO CARDIAC SURGERY FOR EVALUATION, IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. A LHR REVIEW CANNOT BE PERFORMED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN OFF-LABEL USE ABDOMINAL AORTA DACRON TUBE GRAFT SURGERY, TWO HS-1045 HEARTSTRING SEALS CRACKED WHILE LOADING THE SEALS INTO THE DELIVERY TUBE. THE SURGEON CONVERTED TO CONVENTIONAL SURGICAL METHOD OF PLACING A CROSS CLAMP WITH A HAND SEWN ANASTOMOSIS TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL. THIS REPORT IS FOR THE SECOND SEAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention