BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-OPERATIVE POSITION SYSTEM (IOPS)

    MDR report key: 21814419 · Received April 10, 2025

    Report

    Report Number
    3012154226-2025-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 10, 2025
    Manufacturer
    CENTERLINE BIOMEDICAL, INC.
    Product Code
    DQX
    PMA / PMN Number
    K190106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT WAS RELEASED MEETING ALL ACCEPTANCE CRITERIA. THE REPORTER STATED THAT AFTER THE DEVICE WAS INSERTED INTO THE CATHETER AND MANIPULATED FOR A COUPLE MINUTES, THE CATHETER WAS EVENTUALLY IN THE NATIVE CELIAC ARTERY, BUT THE GUIDEWIRE WAS UNABLE TO BE REMOVED. THE REPORTER STATED THERE WAS RESISTANCE FELT ABOUT HALFWAY THROUGH THE CATHETER WHILE IT WAS PULLED OUT OF THE BODY. THE REPORTER HAD TO FORCE THE WIRE OUT, AND UPON REMOVAL, HE NOTICED THE END OF THE WIRE WAS KINKED AND DELAMINATED. 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. THE SUBJECT DEVICE WAS RETURNED FOR INVESTIGATION; HOWEVER, TESTING IS NOT YET COMPLETE AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE IOPS ATW-2 GUIDEWIRE WAS INSERTED INTO A 125CM SIMPLE CURVE VIEWPOINT CATHETER AND ADVANCED INTO THE CELIAC PORTAL OF A TAMBE DEVICE. THE CATHETER WAS INSERTED INTO THE NATIVE CELIAC ARTERY, HOWEVER, THE GUIDEWIRE HAD RESISTANCE UPON REMOVAL. THE WIRE WAS FORCED OUT, WHICH CAUSED THE CATHETER TO POP OUT OF THE CELIAC PORTAL AND THE ENTIRE SYSTEM WAS PULLED OUT OF THE BODY. IT WAS NOTICED UPON REMOVAL THAT THE WIRE WAS KINKED. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518587 INTRA-OPERATIVE POSITION SYSTEM (IOPS) GUIDEWIRE DQX CENTERLINE BIOMEDICAL, INC. ATW-2 2404-2005

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male