BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TALISMAN PFO OCCLUDER

    MDR report key: 18826707 · Received March 4, 2024

    Report

    Report Number
    2135147-2024-00955
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 18, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067033314
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF AIR BUBBLES APPEARED IN THE LOADER WHEN ATTEMPTING TO ADVANCE THE OCCLUDER INTO THE DELIVERY SHEATH WAS REPORTED. ALSO REPORTED THAT ONLY WHEN ALL CONNECTIONS FROM THE SHEATH TO THE LOADER, FROM THE LOADER TO THE HEMOSTASIS VALVE, AND THE HEMOSTASIS VALVE WERE SUBMERGED IN A WATER BATH, THE DEVICE COULD BE ADVANCED WITHOUT BUBBLES. A RETURNED DEVICE INSPECTION, TO RULE OUT ANY DEVICE-RELATED CAUSES, COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF AIR IN LOADER DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. INFORMATION FROM FIELD INDICATED THAT NO AIR ENTERED THE PATIENT ANATOMY AND THAT THE DEVICE WAS IMPLANTED SUCCESSFULLY. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 18-25MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER (LOT: 8864459) WAS CHOSEN FOR IMPLANTATION UTILIZING AN 8F AMPLATZER TALISMAN DELIVERY SHEATH. DURING PREPARATION, WHEN ATTEMPTING TO ADVANCE THE OCCLUDER INTO THE DELIVERY SHEATH, AIR BUBBLES APPEARED IN THE LOADER. ONLY WHEN ALL CONNECTIONS, FROM THE SHEATH TO THE LOADER, FROM THE LOADER TO THE HEMOSTASIS VALVE, AND THE HEMOSTASIS VALVE WERE SUBMERGED IN A WATER BATH, COULD THE DEVICE BE ADVANCED WITHOUT BUBBLES. NO AIR ENTERED THE PATIENT ANATOMY. NO ADDITIONAL ASPIRATION WAS NEEDED TO PREVENT AIR FROM ENTERING THE PATIENT ANATOMY. THE DEVICE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696558 AMPLATZER TALISMAN PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 8864459 05415067033314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown