BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 21978203 · Received May 7, 2025

    Report

    Report Number
    2916596-2025-02758
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 7, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE TO THE MODULAR CABLE¿S OUTER JACKET AND SIGNS OF FLUID INGRESS ON THE CABLE WERE NOT CONFIRMED. A LOG FILE WAS SUBMITTED FOR REVIEW AND DATA FROM THE EVENT DATES OF 15APR2025 ¿ 17APR2025 WERE REVIEWED. THE DATA IN THE LOG FILE DID NOT INDICATE ANY ISSUES WITH THE MODULAR CABLE. THE MODULAR CABLE WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING IF ANY IMAGES OF THE DAMAGE TO THE MODULAR CABLE WERE AVAILABLE FOR REVIEW AND IF ANY PRODUCTS WOULD BE RETURNED FOR ANALYSIS; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 7964945, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ SUBSECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", EXPLICITLY CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. HEARTMATE 3 PATIENT HANDBOOK ( REV. D) SECTION 4 ¿ ¿LIVING WITH THE HEARTMATE 3¿ EXPLAINS HOW TO PROPERLY CARE FOR THE DRIVELINE AND STATES, ¿KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID¿. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 10 ¿ ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. 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 PATIENT ARRIVED TO THE CLINIC WITH A TORN MODULAR CABLE WITH OXIDATION PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819811 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE Ventricular (assist) bypass DSQ THORATEC CORPORATION 106525US 7964945 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male