BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOPS GUIDEWIRE ANGLED TIP 2

    MDR report key: 17119007 · Received June 13, 2023

    Report

    Report Number
    3012154226-2023-00002
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 8, 2023
    Report Date
    June 13, 2023
    Manufacturer
    CENTERLINE BIOMEDICAL
    Product Code
    DQX
    UDI-DI
    00843152102037
    PMA / PMN Number
    K190106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THE LOT WAS RELEASED MEETING ALL ACCEPTANCE CRITERIA. A PICTURE OF THE DAMAGED WIRE TAKEN BY OUR COMPANY REPRESENTATIVE DURING THIS CASE CONFIRMED DELAMINATION OF THE WIRE COATING. AT THIS TIME, WE WERE ABLE TO REPLICATE THIS ISSUE WHEN ONLY USING THE SAME CATHETER (FROM OTHER MANUFACTURER) AS REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    DURING A MINIMALLY INVASIVE VASCULAR SURGERY PERFORMED AT VANDERBILT UNIVERSITY MEDICAL CENTER, DR. ADVANCED THE IOPS GUIDEWIRE ATW-2 THROUGH A CATHETER AND SHEATH (BOTH FROM ANOTHER MANUFACTURER) THAT HAD ALREADY CANNULATED THE PMEG FENESTRATION TO ACCESS THE SMA. THE IOPS WIRE WAS SWITCHED OUT FOR ANOTHER WIRE FROM ANOTHER MANUFACTURER. BEFORE INSERTING IT BACK INTO THE SHEATH TO ACCESS THE CELIAC ARTERY, DR. NOTICED THAT THE WIRE COVERING OVER THE SENSOR WAS BECOMING DETACHED AND DECIDED NOT TO PROCEED ANY FURTHER. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987709 IOPS GUIDEWIRE ANGLED TIP 2 WIRE DQX CENTERLINE BIOMEDICAL ATW-2 QD02QD23 00843152102037

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male