BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SULZER CABOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 93548 · Received May 28, 1997

    Report

    Report Number
    1627803-1997-00007
    Event Type
    Malfunction
    Date Received
    May 28, 1997
    Date of Event
    April 25, 1997
    Report Date
    May 28, 1997
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H6 - EVALUATION CODES. METHOD CODE 86 (OTHER) - DEVICE HISTORY RECORDS REVIEW PERFORMED. RESULT CODE 100 (OTHER) - DEVICE HISTORY RECORDS REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE REQUIREMENTS AT THE TIME OF MANUFACTURE AND RELEASE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING THE IMPLANT OPERATION HE EXPERIENCED DIFFICULTY ROTATING THE PROSTHETIC MITRAL VALVE. HE THEN USED METAL CLAMPS TO ROTATE THE VALVE. THE VALVE BROKE AND WAS REMOVED AND REPLACED. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULZER CABOMEDICS PROSTHETIC HEART VALVE Implant PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. 700 A278471-F

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR