BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS ANGIOGRAPHIC CATHETER 4F, JL4, 100CM

    MDR report key: 514977 · Received March 9, 2004

    Report

    Report Number
    2182269-2004-00038
    Event Type
    Injury
    Date Received
    March 9, 2004
    Date of Event
    January 1, 2004
    Report Date
    March 9, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CARDIAC CATHETERIZATION PROCEDURE, UNDER FLUOROSCOPY, IT WAS NOTED THE SPYGLASS JL4 CATHETER HAD FOLDED WHILE IN THE ARTERY. THE CATHETER TIP WAS REMOVED THROUGH THE INTRODUCER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS ANGIOGRAPHIC CATHETER 4F, JL4, 100CM SPYGLASS 4F, JL4 DQO ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 1021821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention