BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    MDR report key: 7991796 · Received October 22, 2018

    Report

    Report Number
    3007042319-2018-04956
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 2, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) SHOULDER PACK (LOT #1050199) WAS NOT RETURNED FOR EVALUATION. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH DAMAGED HOOKS CAN BE ATTRIBUTED, BUT NOT LIMITED TO WEAR AND/OR DUE TO THE HANDLING OF THE PACK. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE UNIT WAS NOT AVAILABLE FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOOK OF THE VENTRICULAR ASSIST DEVICE (VAD) SHOULDER PACK "COMES OUT FROM ITS HOUSE." THE PACK WAS REMOVED FROM SERVICE AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833889 HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 2060 1050199

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 1104 VAD| 1104 VAD