BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-OPERATIVE POSITIONING SYSTEM (IOPS)

    MDR report key: 21306703 · Received February 4, 2025

    Report

    Report Number
    3012154226-2025-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 3, 2025
    Manufacturer
    CENTERLINE BIOMEDICAL, INC.
    Product Code
    DQX
    UDI-DI
    00843152102037
    PMA / PMN Number
    K190106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THE LOT WAS RELEASED MEETING ALL ACCEPTANCE CRITERIA. THE HYDROPHILIC COATING ON THE DISTAL END OF THE GUIDEWIRE WAS VISUALLY CONFIRMED TO BE PARTIALLY PEELED BUT WAS STILL ATTACHED TO THE GUIDEWIRE. THE TRACKING DATA FROM THE PROCEDURE WAS USED TO CREATE A VIDEO PLAYBACK SIMULATION OF THE GUIDEWIRE AND CATHETER POSITIONS INSIDE THE PATIENT'S ANATOMY WHEN THE ISSUE OCCURRED. BASED ON THIS SIMULATION, IT IS LIKELY THAT THE DAMAGE WAS CAUSED BY THE PATIENT'S TORTUOUS ANATOMY WHICH FORCED THE GUIDEWIRE INTO A SHARP ANGLE (>90°) AND THE USER RAPIDLY RETRACTING THE GUIDEWIRE WHEN RESISTANCE WAS FELT. THE GUIDEWIRE INSTRUCTIONS FOR USE (IFU) HAVE BEEN UPDATED TO INCLUDE A WARNING RELATED TO DEVICE MANIPULATION AND INSTRUCTIONS ON HOW TO PROCEED IF ANY RESISTANCE IS FELT BUT THE GUIDEWIRE LOT USED DURING THIS EVENT DID NOT CONTAIN THIS UPDATED IFU.

    Description of Event or Problem · 0

    DURING A BEVAR (BRANCHED ENDOVASCULAR AORTIC REPAIR) PROCEDURE, AN IOPS ATW-2 GUIDEWIRE WAS DAMAGED UPON REMOVAL FROM THE PATIENT. DURING REMOVAL, THE PHYSICIAN NOTED SOME RESISTANCE BUT CONTINUED TO RETRACT THE GUIDEWIRE. AFTER THE GUIDEWIRE WAS REMOVED, IT WAS FOUND THAT THE HYDROPHILIC COATING ON THE DISTAL TIP HAD BEGUN TO DELAMINATE. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094432 INTRA-OPERATIVE POSITIONING SYSTEM (IOPS) GUIDEWIRE DQX CENTERLINE BIOMEDICAL, INC. ATW-2 2404-2005 00843152102037

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male