BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 349456 · Received August 30, 2001

    Report

    Report Number
    2210968-2001-00455
    Event Type
    Injury
    Date Received
    August 30, 2001
    Report Date
    August 2, 2001
    Manufacturer
    HEARTPORT INC.
    Product Code
    DWF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT AT 7TH ANNUAL CARDIOTHORACIC TECHNIQUES AND TECHNOLOGIES MEETING, 2001 THAT BETWEEN 1997 AND 2000, 163 CASES OF MITRAL VALVE REPAIR OR REPLACEMENT WERE PERFORMED USING PORT-ACCESS INSTRUMENTATION. FOUR PATIENTS REQUIRED CONVERSION TO STERNOTOMY DUE TO AORTIC DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39480 ENDOCLAMP AORTIC CATHETER CATHETER DWF HEARTPORT INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention