BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-WAIST PACK

    MDR report key: 7174662 · Received January 9, 2018

    Report

    Report Number
    3007042319-2018-00129
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 15, 2017
    Report Date
    April 23, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000048
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE WAIST PACK (LOT NO 1211639) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED WAIST PACK REVEALED DAMAGED SEAMS ON THE CONTROLLER POCKET OF THE PATIENT¿S WAIST PACK. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO DETERIORATION AND/OR DUE TO THE HANDLING OF THE PACK. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 WAIST PACK WAS DAMAGED. THE MAIN STRAP OF THE PACK WAS TORN. THIS COULD HAVE RESULTED IN THE PERIPHERALS DROPPING FROM THE PATIENT¿S WAIST AND PULLING THE DRIVELINE. THE PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19256 HEARTWARE VENTRICULAR ASSIST SYSTEM-WAIST PACK VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 2050 1211639 00888707000048

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR (B)(4).