BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXOR CHECK-FLO INTRODUCER

    MDR report key: 21739724 · Received April 1, 2025

    Report

    Report Number
    MW5168448
    Event Type
    Death
    Date Received
    April 1, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 28, 2025
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS 88 Y/O FEMALE HAD PLANNED ANGIOGRAM WITH ATTEMPT FOR REVASCULARIZATION TO IMPROVE WOUND HEALING OF HER RIGHT FOOT; SHE HAS SIGNIFICANT ATHEROSCLEROTIC PERIPHERAL ARTERY DISEASE. DURING THE PROCEDURE, PROVIDER WAS PERFORMING A SHEATH EXCHANGE (5/90 COOK- SHEATH IS 90CM LONG) AND THE SHEATH AND WIRE SHEARED INSIDE THE VESSEL. THERE WAS RETAINED SHEATH/WIRE AND VASCULAR WAS CONTACTED FOR EMERGENT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171177 FLEXOR CHECK-FLO INTRODUCER INTRODUCER, CATHETER DYB COOK MEDICAL LLC. KCFW-5.0-38-90-RB-RAABE 16394943

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Death| L