BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 8784602 · Received July 12, 2019

    Report

    Report Number
    2135147-2019-00194
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    October 4, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    UDI-DI
    00811806011110
    PMA / PMN Number
    P020024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 1

    09/06/2019 MJR ¿ SUPPLEMENTAL REPORT NEEDED TO ADDRESS ANALYSIS: THE REPORTED EVENT OF A DETACHED MALE END SCREW OF THE DELIVERY CABLE WAS CONFIRMED. ONE FLUORO IMAGE WAS RECEIVED FROM THE FIELD, WHICH DISPLAYED THE DEPLOYED OCCLUDER WITH THE DISTAL END OF THE DELIVERY CABLE STILL ENGAGED WITHIN ITS END SCREW. THE REPORTED DIFFICULTY DETACHING THE DEVICE COULD NOT BE INVESTIGATED, AS THE OCCLUDER ITSELF REMAINS IMPLANTED AND WAS THERE FOR NOT ACCESSIBLE FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE DELIVERY CABLE. THE DELIVERY CABLE WAS RECEIVED, WITH THE INVESTIGATION RESULTS DETAILED IN MDR-2019-27858.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN THE DUCTUS USING A 6F 180/80MM AMPLATZER TORQVUE DELIVERY SYSTEM (LOT NUMBER: 6942209). WHILE RELEASING THE DEVICE, THE SITE HAD DIFFICULTY LOOSENING THE DELIVERY CABLE. THE CABLE SNAPPED OFF RATHER THEN UNSCREW, AND PART REMAINED CONNECTED TO THE DEVICE. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IN PLACE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578531 AMPLATZER DUCT OCCLUDER OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE AGA MEDICAL CORPORATION 9-PDA-004 6983935 00811806011110

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR