BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 10504745 · Received September 8, 2020

    Report

    Report Number
    2135147-2020-00396
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 18, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010199
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10,G4, H2, H3, H6 & H10. THE REPORTED EVENT OF DEVICE DEFORMATION COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET VISUAL AND FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    ON (B)(6) 2020 A 24MM ASD DEVICE (9-ASD-024 LOT# 6905183) WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE IT WAS DISCOVERED BY THE USER TO DEFORMED, REPORTING A "COBRA HEAD" SHAPE. A NEW 24MM DEVICE WAS PREPARED AND USED TO SUCCESSFULLY COMPLETE THE SURGERY WITHOUT INCIDENT. (9-ASD-024 LT#7101837).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969178 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-024 6905183 00811806010199

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention