BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    COOK MEDICAL INC.

    MDR report key: 12736325 · Received November 2, 2021

    Report

    Report Number
    3008988055-2021-00002
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 23, 2021
    Manufacturer
    HERAEUS MEDICAL COMPONENTS
    Product Code
    DQX
    UDI-DI
    00816840020777
    PMA / PMN Number
    K191502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF THIS REPORT: 23-SEPT-2021

    Additional Manufacturer Narrative · 1

    REPORT DELAYED DUE TO ESUBMITTER SETUP ISSUES; COMMUNICATED WITH FDA REGARDING THIS DELAY (B)(6) 2021.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT AN INTERVENTION SFA CTO IN WHICH THE APPROACH AUTHORITY WORKHORSE MICROWIRE GUIDE, ,018 WIRE DIAMETER, 300CM LENGTH, 6.5CM POLYMER LENGTH, 8CM TAPER LENGTH, G57804, WAS USED. TIBIAL ACCESS, ATTEMPTING TO CROSS CALCIFIED CTO OF SFA WITH AUTHORITY WIRE THROUGH 018 ANGLED CXI. PROLAPSED TIP TRYING TO PUSH THROUGH CTO, WIRE AND CATHETER ENTERED SUBINTIMAL SPACE. AFTER A LITTLE BIT OF MANEUVERING A PORTION OF THE TIP OF THE WIRE BROKE. DISTAL TIP OF THE WIRE BROKE OFF AND WEDGED INTO THE SUBINTIMAL SPACE, MD [THE PHYSICIAN] DECIDED TO LEAVE BROKEN TIP AND NOT TRY TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634892 COOK MEDICAL INC. APPROACH AUTHORITY WORKHORSE MICROWIRE GUIDE DQX HERAEUS MEDICAL COMPONENTS AUTH-18-300 9007497392 00816840020777

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other