BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F

    MDR report key: 1012480 · Received March 12, 2008

    Report

    Report Number
    2182269-2008-00083
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    January 28, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS AWAITING DEVICE RETURN. ONCE THE ANALYSIS HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AIR LEAK WAS NOTED AT THE VALVE DURING THE PROCEDURE. AN 8F NAVISTAR DEVICE WAS ALSO USED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F SWARTZ TRANSSEPTAL SL1 DYB ST. JUDE MEDICAL NA 2023395

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK