BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPLOYMENT CATHETER AND LOADER, 2.6

    MDR report key: 16925146 · Received May 13, 2023

    Report

    Report Number
    3004450998-2023-00034
    Event Type
    Malfunction
    Date Received
    May 13, 2023
    Report Date
    June 9, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    OAZ
    UDI-DI
    00896506002187
    PMA / PMN Number
    HDE H060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPLOYMENT CATHETER AND LOADER WAS RETURNED TO GYRUS ACMI, INC. FOR EVALUATION. INITIAL INSPECTION OF THE DEPLOYMENT CATHETER SHOWED IT WAS BENT AT THE DISTAL END. FURTHER INSPECTION OF CATHETER TIP SHOWED A KINKED/ BENT STABILIZATION WIRE. UPON OPENING THE LOADER, TWO VALVES WERE FOUND TO BE STUCK IN THE LOADER. THE VALVES WERE REMOVED FROM THE LOADER, INDICATING THE SECOND VALVE APPEARS TO HAVE BEEN FORCIBLY LOADED WITHOUT DEPLOYING THE FIRST VALVE, LEADING TO DAMAGE OF THE DEPLOYMENT CATHETER AND THE VALVES.

    Additional Manufacturer Narrative · 0

    MEDICAL STAFF REPORTED THERE WAS NO PATIENT INJURY. FOLLOW-UP TO OBTAIN ADDITIONAL EVENT INFORMATION IS ONGOING. THE DEPLOYMENT CATHETER AND LOADER IS BEING RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. NO VALVES WILL BE RETURNED.

    Description of Event or Problem · 0

    PATIENT WAS TO HAVE SPIRATION VALVES (HUS-V9) PLACED FOR THE TREATMENT OF AIR LEAK (DATE UNKNOWN). PHYSICIAN USED THE SPIRATION DEPLOYMENT CATHETER AND LOADER (HUS-C26N) TO PLACE THE SPIRATION VALVES. VALVES COULD NOT BE PLACED. PHYSICAN REPORTED THREE WASTED VALVES (HUS-V9) DUE TO A MALFUNCTIONING DEPLOYMENT CATHETER AND LOADER (HUS-C26N). REPLACEMENT DEVICES WERE SENT RESULTING IN A 24-HOUR DELAY IN PROCEDURE. NO PATIENT INJURY OCCURRED.

    Description of Event or Problem · 0

    PATIENT WAS TO HAVE SPIRATION VALVES (HUS-V9) PLACED FOR THE TREATMENT OF AIR LEAK (DATE UNKNOWN). PHYSICIAN USED THE SPIRATION DEPLOYMENT CATHETER AND LOADER (HUS-C26N) TO PLACE THE SPIRATION VALVES. VALVES COULD NOT BE PLACED. PHYSICIAN REPORTED THREE WASTED VALVES (HUS-V9) DUE TO A MALFUNCTIONING DEPLOYMENT CATHETER AND LOADER (HUS-C26N). REPLACEMENT DEVICES WERE SENT RESULTING IN A 24-HOUR DELAY IN PROCEDURE. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184649 DEPLOYMENT CATHETER AND LOADER, 2.6 SPIRATION VALVE CATHETER AND LOADER OAZ GYRUS ACMI, INC. HUS-C26N WS326739 00896506002187

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization