BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 8791391 · Received July 15, 2019

    Report

    Report Number
    2135147-2019-00193
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 14, 2019
    Report Date
    October 4, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    UDI-DI
    00811806010779
    PMA / PMN Number
    K072313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    09/06/2019 MJR ¿ SUPPLEMENTAL REPORT NEEDED TO ADDRESS ANALYSIS: THE DETACHED END SCREW OF THE DELIVERY CABLE WAS CONFIRMED. THE DETACHMENT DIFFICULTY COULD NOT BE INVESTIGATED, AS THE END SCREW REMAINS ATTACHED TO THE IMPLANTED DEVICE. THE ROOT CAUSE OF THE DISTAL END OF THE DELIVERY CABLE DETACHING WAS TRACED TO THE LASER WELDING PROCESS, AS THE EXPOSED CORE WIRE OF THE RETURNED PORTION OF THE DELIVERY CABLE EXHIBITED NO EVIDENCE OF WELD PENETRATION. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    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
    585543 AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY AGA MEDICAL CORPORATION 9-ITV06F180/80 6942209 00811806010779

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR