BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.035" ANGTIP HYBRID WIRE BX/5

    MDR report key: 17131795 · Received June 14, 2023

    Report

    Report Number
    2429304-2023-00191
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 14, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    EYA
    UDI-DI
    00821925031432
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE 0.035" ANGLED TIP, HYBRID GUIDEWIRE HAD BLACK FLAKES COMING OFF WHILE INSIDE THE PATIENT DURING USE. THE ISSUE OCCURRED DURING AN UNIDENTIFIED, DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH ANOTHER GUIDEWIRE. THE PROCEDURE HAD TO BE EXTENDED BY 10 MINUTES WHILE THE BLACK FLAKES WERE RETRIEVED FROM INSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT DUE TO THE DELAY. RELATED PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408598 0.035" ANGTIP HYBRID WIRE BX/5 0.035" HYBRID WIRE, BOX OF 5 EYA GYRUS ACMI, INC. GWH3505RA 91905597 00821925031432

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention