BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSWALK

    MDR report key: 12303167 · Received August 10, 2021

    Report

    Report Number
    3004718255-2021-00233
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 9, 2021
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQY
    UDI-DI
    04547327133494
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT CODE IS DQY FOR CATHETER BUT THIS CODE IS NOT POPULATING THE INFORMATION FOR THIS 3500A.

    Description of Event or Problem · 1

    THE CATHETER TIP FELL OFF DURING A RANDOM SFA PROCEDURE. NOT OVERLY CALCIFIED OR TORTOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201850 CROSSWALK PERIPHERAL SUPPORT CATHETER DQY ASAHI INTECC CO., LTD. PSC18090A 210406K02A 04547327133494

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other