BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 TUNNELING LANCE AND HANDLE

    MDR report key: 20923433 · Received December 13, 2024

    Report

    Report Number
    2916596-2024-52575
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    December 6, 2024
    Report Date
    April 2, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067038432
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED TUNNELING LANCE CONFIRMED THE REPORTED CONNECTION ISSUE, WHICH WAS FOUND TO BE DUE TO DEFORMATION OF THE TUNNELING LANCE END; HOWEVER, A SPECIFIC CAUSE FOR THE DEFORMATION COULD NOT BE CONCLUSIVELY DETERMINED. A USED, 16¿ TUNNELING LANCE WAS RETURNED FOR EVALUATION. ONE OF THE ENDS THAT INTERACTS WITH THE TUNNELER HANDLE WAS DEFORMED WHILE THE OTHER APPEARED NORMAL. THE RETURNED TUNNELER WAS MEASURED TO BE WITHIN SPECIFICATION AT THE THICKEST PART OF THE TUNNELER THREADS AND AT THE HEXAGONAL HEIGHTS OF ITS ENDS. THE DEFORMATION OF THE TUNNELER END, WHERE IT INTERACTS WITH THE HANDLE, WAS MEASURED AND FOUND THAT IT COULD HAVE CAUSED A CONNECTION ISSUE. CONNECTION WAS ATTEMPTED BETWEEN THE RETURNED TUNNELER AND A TEST HANDLE, AS THE HANDLE WAS NOT RETURNED. THE NORMAL TUNNELER END WAS ABLE TO BE FIT INTO THE HANDLE WITHOUT ISSUE, WHILE THE DEFORMED TUNNELER END WAS NOT ABLE TO BE FULLY FIT INTO THE TEST HANDLE. THE CAUSE OF THE CONNECTION ISSUE APPEARED TO BE THE DEFORMATION OF THE TUNNELER END; HOWEVER, A SPECIFIC CAUSE FOR THE DEFORMATION COULD NOT BE CONCLUSIVELY DETERMINED. THE RELEVANT SECTIONS OF THE AVAILABLE DEVICE HISTORY RECORDS WERE REVIEWED, WHICH SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. IT WAS UNABLE TO BE CONCLUSIVELY DETERMINED WHICH ABBOTT BATCH # THE RETURNED DEVICE WAS FROM USING ONLY THE SUPPLIER BATCH #880931, SO THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR ALL POSSIBLE BATCH #¿S (7082763, 7082764, AND 7082812) WERE REVIEWED WHICH SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 5 ¿SURGICAL PROCEDURES¿ (UNDER ¿CREATING THE EXIT SITE¿) PROVIDES INSTRUCTIONS FOR USE OF THE TUNNELING LANCE AND HANDLE. THIS SECTION CAUTIONS THE USER THAT "THE HEARTMATE 3 TUNNELING LANCE AND HANDLE ARE PROVIDED NON-STERILE. ENSURE THAT THE LANCE AND HANDLE HAVE BEEN CLEANED, INSPECTED, AND STERILIZED IN ACCORDANCE WITH THE PROVIDED INSTRUCTIONS AND HOSPITAL POLICY." THE HEARTMATE III LVAS SURGICAL TOOLS CLEANING AND STERILIZATION IFU PROVIDES INFORMATION REGARDING THE CLEANING, DRYING, PACKAGING, STERILIZATION, STORAGE, AND MAINTENANCE OF HEARTMATE 3 SURGICAL TOOLS, INCLUDING THE TUNNELING LANCE AND HANDLE, AND CAUTIONS THAT THE PROVIDED INSTRUCTIONS MUST BE FOLLOWED TO ENSURE PROPER STERILITY LEVELS AND DEVICE FUNCTIONALITY. IN ADDITION, THIS DOCUMENT STATES THAT END OF LIFE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. THE USER MUST ENSURE THAT THE TUNNELING LANCE CAN BE INSERTED AND REMOVED FROM THE HANDLE. THIS IFU CAUTIONS THE USER THAT IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, THE EQUIPMENT SHOULD NOT BE USED, AND THE APPROPRIATE RESPONSIBLE PERSON SHOULD BE NOTIFIED. THIS DOCUMENT FURTHER CAUTIONS THAT THE INSTRUMENT MAY NEVER BE HEATED TO ABOVE 140°C. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUNNELING LANCE (SHORT VERSION) WAS NO LONGER ABLE TO BE CONNECTED TO THE HANDLE ON ONE SIDE. THE BACKUP TUNNELER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859397 HEARTMATE 3 TUNNELING LANCE AND HANDLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106533 05415067038432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown