BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7733663 · Received July 30, 2018

    Report

    Report Number
    2916596-2018-03115
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    April 23, 2018
    Report Date
    October 29, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP REMAINS IMPLANTED AND THE PATIENT CONTINUES ON VAD SUPPORT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER HAS CLOSED THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURER. INVESTIGATION SUMMARY: THE REPORT OF A PRONG ON THE TUNNELING ADAPTER BREAKING OFF COULD NOT BE CONFIRMED AS NO IMAGES WERE PROVIDED AND THE TUNNELING ADAPTER ASSEMBLY, LOT NUMBER 193377, WAS NOT RETURNED FOR INVESTIGATION. THE ACCOUNT COMMUNICATED THAT A PRONG ON THE TUNNELING ADAPTER BROKE OFF WHILE TUNNELING THE DRIVELINE. NO ACTIONS WERE TAKEN AS THE PATIENT WAS NOT HARMED BY THIS EVENT. IT WAS REPORTED THAT THE TUNNELING ADAPTER WAS DISCARDED. THE PATIENT REMAINS ONGOING ON MLP-008647 AND NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS IFU DESCRIBES HOW TO ATTACH THE TUNNELING ADAPTER AND HOW TO CREATE THE DRIVELINE EXIT SITE. THIS DOCUMENT ALSO INSTRUCTS THE USER TO CONFIRM THAT THE YELLOW LINE ON THE TUNNELING ADAPTER IS FULLY COVERED FOR A SECURE CONNECTION.THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS (DOCUMENTS 201030 AND 193377) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. PATIENT REMAINS ONGOING ON THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    AGE OF DEVICE: 0 DAYS. THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED WHILE TUNNELING THE DRIVELINE, IT WAS NOTED THAT A PRONG ON THE TUNNELING ADAPTER BROKE OFF. PATIENT WAS ASYMPTOMATIC. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575545 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR