BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-OPERATIVE POSITION SYSTEM (IOPS)

    MDR report key: 21483142 · Received February 27, 2025

    Report

    Report Number
    3012154226-2025-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 27, 2025
    Manufacturer
    CENTERLINE BIOMEDICAL, INC.
    Product Code
    DQX
    PMA / PMN Number
    K190106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT WAS RELEASED MEETING ALL ACCEPTANCE CRITERIA. A PHOTO PROVIDED BY THE REPORTER VISUALLY CONFIRMED THAT THE HYDROPHILIC COATING ON THE DISTAL END OF THE GUIDEWIRE HAD DEGLOVED FROM THE WIRE. THE REPORTER NOTED THAT THE COATING WAS INTACT AND NOT TATTERED. THEY ALSO STATED THAT THE PATIENT'S ANATOMY WAS NEITHER TORTUOUS NOR CALCIFIED AND CLARIFIED THAT NO ADDITIONAL DEVICES CROWDED THE SHEATH OR CATHETER. THE REPORTER FURTHER EXPLAINED THAT THE PHYSICIAN PERFORMED THE CANNULATION USING A STANDARD TECHNIQUE, WHICH INVOLVED LIGHTLY TWIRLING THE WIRE WHILE GENTLY ADVANCING IT - AN APPROACH COMMONLY USED WHEN CANNULATING RENAL ARTERIES TO MINIMIZE THE RISK OF DISSECTION. GUIDEWIRE WAS INSERTED INTO THE PATIENT, USED, AND THEN REMOVED WITHOUT DELAMINATION. AFTER SITTING FOR A PERIOD OF TIME THE GUIDEWIRE WAS REINSERTED, USED, AND UPON REMOVAL FOR THE SECOND TIME THE DELAMINATION WAS NOTED. THE INSTRUCTIONS FOR USE (IFU) HAD PREVIOUSLY BEEN UPDATED TO INCLUDE A WARNING RELATED TO DEVICE MANIPULATION AND GUIDANCE ON HOW TO PROCEED IN CASES OF RESISTANCE; HOWEVER, THIS VERSION OF THE IFU WAS NOT INCLUDED WITH THE SUBJECT DEVICE. IT REMAINS UNCLEAR WHETHER RESISTANCE OCCURRED DURING THE EVENT. THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION; HOWEVER, TESTING IS NOT YET COMPLETE AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    DURING AN ATTEMPT AT A BILATERAL RENAL CANNULATION, AN IOPS ATW-2 GUIDEWIRE WAS DAMAGED UPON REMOVAL FROM THE PATIENT. IT WAS NOTICED THAT THERE WAS MATERIAL HANGING FROM THE TIP OF THE WIRE UPON REMOVAL. THE MATERIAL WAS IDENTIFIED AS THE COATING OF THE TIP OF THE WIRE. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568082 INTRA-OPERATIVE POSITION SYSTEM (IOPS) GUIDEWIRE DQX CENTERLINE BIOMEDICAL, INC. ATW-2 2404-2005

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female