BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 806354 · Received January 5, 2007

    Report

    Report Number
    2135147-2007-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2007
    Date of Event
    December 6, 2006
    Report Date
    January 5, 2007
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE REPORTS BY A MEDICAL PROFESSIONAL RESULTED IN THE FOLLOWING FINDINGS: FOUR ASO DEVICES ARE PLACED IN ATRIAL SEPTUM. THREE ARE DEPLOYED AND TWO RELEASED WITHOUT INCIDENT. DURING DEPLOYMENT OF FOURTH DEVICE, THE MICROSCREW SEPARATED FROM THE DEVICE LEAVING THE WELDED RA DISC IN PLACE AND THE MICROSCREW INSIDE THE DELIVERY SHEATH ATTACHED TO THE CABLE. THE EMPTY "CUP" OF THE MICROSCREW WHERE THE WELDED BRAID CAME LOOSE IS VISIBLE. DEVICE POSITIONS WERE SATISFACTORY AND THE "THIRD" DEVICE WAS SAFELY RELEASED. THE WELD OF THE BRAID ON ONE DEVICE SEPARATED INSIDE OF THE MICROSCREW LEAVING THE MICROSCREW ATTACHED TO THE DELIVERY CABLE AND WELDED BRAID OF THE DEVICE INTACT. THERE IS NO EVIDENCE OF SEPARATION OF THE WELDED BRAID OF THE RA DISC. SINCE BEING NOTIFIED OF THE EVENT, AGA MEDICAL HAS REQUESTED RETURN OF THE END SCREW CAP AND THE DELIVERY CABLE FROM THE PHYSICIAN ON 12/7/2006, 12/14/2006, 12/22/2006 AND 1/5/2006. AS OF THE FILING OF THIS REPORT, THE REQUESTED COMPONENTS HAVE NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE DEVICE PROBLEM WAS WITH A 17MM ASO DEVICE IN WHICH THE STEEL THREADED COLLAR WHERE THE CABLE WAS ATTACHED BROKE OFF DURING THE NORMAL DEPLOYMENT SEQUENCE, PREMATURELY RELEASING THE DEVICE. FORTUNATELY, THE COLLAR BROKE OFF IMMEDIATELY AFTER THE RIGHT ATRIAL DISC WAS DEPLOYED OUT OF THE SHEATH AND NOT BEFORE, THEREFORE EMBOLIZATION WAS AVOIDED. THE DEVICE HAD NOT BEEN PREVIOUSLY RECAPTURED OR MANIPULATED IN ANY WAY PRIOR TO THIS DEPLOYMENT. THE PATIENT IS FINE AND THE DEVICE LOOKS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-017 M05H15-25

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR 8F AMPLATZER DELIVERY SYSTEM (LOT NUMBER UNKNOWN)