BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5834899 · Received July 29, 2016

    Report

    Report Number
    3007042319-2016-02729
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 8, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    UDI-DI
    00888707000154
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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, INCLUDING TRANSPORTATION. AN APICAL CORING TOOL WAS RETURNED FOR ANALYSIS. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE SURGICAL TOOL IN RELATION TO THE REPORTED EVENT. THE REPORTED EVENT OF CORING TOOL "DAMAGE" WAS CONFIRMED AS THE RETURNED DEVICE SHOWED DAMAGE (FRACTURE) AT THE CUTTER EDGE OF THE REVERSE CORE. DIMENSIONAL VERIFICATION, FUNCTIONAL TEST, MATERIAL IDENTIFICATION, HARDNESS, AND DHR REVIEW DID NOT IDENTIFY DEVIATIONS FROM SPECIFICATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. VISUAL EVIDENCE SHOWS EVIDENCE OF CORROSION; HOWEVER, IT CANNOT BE DETERMINED WHETHER THE CORROSION WAS A PRE-EXISTING CONDITION PRIOR TO USE. IN ADDITION THE UNIT PASSED THE COPPER SULFATE TEST FOR VERIFICATION OF PASSIVATION AND HARDNESS WAS FOUND WITHIN CURRENT SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MULTIPLE FACTORS MAY HAVE PLAYED A ROLE ON THE REPORTED EVENT, INCLUDING BUT NOT LIMITED TO; EXCESSIVE FORCE APPLIED TO THE UNIT, DAMAGE INDUCED PRIOR TO USE, AND/OR DEFECTIVE COMPONENT. A MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY IDENTIFIED FROM THE INVESTIGATION PERFORMED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MULTIPLE FACTORS MAY HAVE PLAYED A ROLE ON THE REPORTED EVENT, INCLUDING BUT NOT LIMITED TO; EXCESSIVE FORCE APPLIED TO THE UNIT, DAMAGE INDUCED PRIOR TO USE, AND/OR DEFECTIVE COMPONENT. A MOST PROBABLE ROOT CAUSE CANNOT BE CONCLUSIVELY IDENTIFIED FROM THE INVESTIGATION PERFORMED. THE INSTRUCTIONS FOR USE (IFU) STATES THAT ALL THE TOOLS AND ACCESSORIES USED DURING IMPLANTATION ARE FOR SINGLE-USE ONLY. IT FURTHER STATES TO EXAMINE ALL COMPONENTS, INCLUDING THE SURGICAL TOOLS, FOR DAMAGE, CORROSION OR ANY ABNORMALITIES THAT MIGHT AFFECT THE SAFETY OR FUNCTIONALITY OF THE TOOLS. IF ANY ABNORMALITIES ARE NOTED PLEASE USE THE APPROPRIATE BACKUP SUPPLIES. IFU OUTLINES PROPER USE AND TECHNIQUES FOR USE OF THE APICAL CORING TOOL. THE REPORTED EVENT COULD NOT BE CONFIRMED DURING TESTING; NO MECHANICAL ISSUES WERE FOUND DURING TESTING. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT IT WAS NOTED THAT THERE WAS DIFFICULTY IN CORING THE LEFT VENTRICULAR APEX. THE CORING TOOL WAS INSPECTED AND WAS NOTED TO HAVE A "JAGGED EDGE". THE PATIENT WAS STABLE POST-IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486708 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 00888707000154

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR