BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOGRAPHY

    MDR report key: 1082014 · Received July 22, 2008

    Report

    Report Number
    2024168-2008-00589
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQO
    PMA / PMN Number
    K000825
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: SHAFT SEPARATION COULD CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: DISTAL SHAFT SEPARATION. IT WAS REPORTED THAT WHILE UNPACKING THE 5.0 JL JOGRAPHY CATHETER THE DISTAL END WAS SEPARATED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOGRAPHY DQO ABBOTT VASCULAR-CARDIAC THERAPIES NA 391579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK