BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING II PROXIMAL SEAL SYSTEM

    MDR report key: 1181042 · Received September 29, 2008

    Report

    Report Number
    2953148-2008-00817
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL INSPECTION VERIFIES THE SEAL IS OUTSIDE THE DEPLOYMENT TUBE AND CRACKED. THE REPORTED COMPLAINT IS CONFIRMED. LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT, THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, ONE HEARTSTRING SEAL FELL APART WHILE LOADING THE SEAL INTO THE DELIVERY TUBE. THE SURGEON USED A REPLACEMENT HEARTSTRING SEAL TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING II PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-1045 8070971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA