BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER¿

    MDR report key: 14753804 · Received June 21, 2022

    Report

    Report Number
    14753804
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 19, 2022
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 1ST DEVICE WAS PREPPED, FLUSHED WITH HEP SALINE AND AMPLATZER LOADED TO THE DELIVERY SYSTEM AND THE DEVICE WAS FLUSHED. WHEN THE DEVICE WAS DEPLOYED INTO THE PULMONARY ARTERY IT SEEMED MISSHAPENED AND IT WOULD NOT ALLOW FOR CLOSURE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT THE AMPLATZER TRIED TO RESHAPE AND CHECK THE CLOSURE BUT DIDN¿T SEEM TO WORK PROPERLY (LOT NUMBER 8031289) ANOTHER DEVICE WAS USED, PREPPED IN THE SAME FASHION. THE 2ND DEVICE WHEN LOADED SEEMED LIKE IT WASN¿T TRACKING WELL ON THE DELIVERY GUIDE AND THE TORQUE WAS HUNG UP MIDWAY THROUGH, IT WAS EVEN FORCED A LITTLE TO PUSH IT THROUGH BUT STILL WAS HUNG UP. (LOT # ON 2ND DEVICE 7712846). DELIVERY AND A 3RD DEVICE WAS USED AND WORKED. SO, IT WAS UNKNOW IF THE DEVICES WERE DEFECTIVE OR THE DELIVERY WAS DEFECTIVE. (DELIVERY LOT # 8412603).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162142 AMPLATZER¿ TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-010 8031289

    Patients

    Seq Age Sex Outcome Treatment
    1 Female