BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.035" ANGTIP HYBRID WIRE BX/5

    MDR report key: 17131815 · Received June 14, 2023

    Report

    Report Number
    3011050570-2023-00067
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 16, 2023
    Report Date
    October 12, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    EYA
    UDI-DI
    00821925031432
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE SUBJECT DEVICE WAS NOT RETURNED AND A SPECIFIC ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE IDENTIFIED WITH THE INFORMATION RECEIVED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00190.

    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, BUT 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
    1409346 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 RIGID SCOPE