BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM

    MDR report key: 1230041 · Received November 12, 2008

    Report

    Report Number
    2953148-2008-00903
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSP DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSP.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING SEAL WAS LOADED CORRECTLY; HOWEVER, AFTER THE SEAL WAS DEPLOYED, THE SURGEON ADJUSTED THE SEAL CABLE (STEM) AND HE PULLED ON THE SEAL CABLE TOO EARLY. THE SEAL BECAME UNRAVELED AND DID NOT PROVIDE HEMOSTASIS. A SECOND SEAL WAS LOADED AND WITH THE SAME MANIPULATION TECHNIQUE, THE SEAL BECAME UNRAVELED. THE SURGEON CHOSE TO USE A SIDE BITER CLAMP TO COMPLETE THE PROCEDURE. THERE WAS NO PT EFFECT REPORTED. THE SURGEON ADMITTED IT WAS USER TECHNIQUE AND THAT HE PULLED THE SEAL STEM TOO EARLY. THERE WAS NO PRODUCT ISSUE RELATED AS THE SURGEON EXPLAINED TO MAQUET TERRITORY MGR SALES REP. THIS REPORT IS FOR THE SECOND SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-3045 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention