BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 22385634 · Received July 2, 2025

    Report

    Report Number
    2916596-2025-04413
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 14, 2025
    Report Date
    August 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION G1: MANUFACTURING SITE NAME CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE TO THE MODULAR CABLE WAS CONFIRMED VIA ANALYSIS OF THE RETURNED CABLE. VISUAL OF THE RETURNED MODULAR CABLE (LOT NUMBER: 8854654) REVEALED A TEAR IN THE POLYURETHANE JACKET APPROXIMATELY 5¿ FROM THE INLINE CONNECTOR BEND RELIEF THAT WAS EXPOSING THE UNDERLYING BRAIDED LAYER. THE OUTER JACKET WAS ALSO OBSERVED TO HAVE A GRAY DISCOLORATION. ADDITIONALLY, THE CONTROLLER CONNECTOR BEND RELIEF HAD A BROWN DISCOLORATION, AND THE INLINE CONNECTOR BEND RELIEF HAD A DARK BROWN DISCOLORATION. THE MODULAR CABLE WAS CONNECTED TO THE RETURNED SYSTEM CONTROLLER AND A TEST PUMP AND SUCCESSFULLY OPERATED THE TEST PUMP WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MODULAR CABLE WAS MANIPULATED BY HAND. LOG FILES WERE SUBMITTED AND DOWNLOADED FOR REVIEW AND THE DATA IN THE LOG FILES DID NOT INDICATE ANY ISSUES WITH THE MODULAR CABLE. THE PUMP MAINTAINED A SPEED WITHIN THE LOW-SPEED LIMIT WITHOUT ANY ISSUES WHILE THE DRIVELINE WAS CONNECTED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED (SHOP ORDER (B)(4)) AND THE RECORDS REVEALED THAT THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 8854654, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK 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 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 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 IFU 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 HAD MULTIPLE EMERGENCY BACKUP BATTERY (EBB) FAULT ALARMS. THE EBB WAS EXCHANGED AND RE-SEATED MULTIPLE TIMES. ON (B)(6) 2025, THE PATIENT REPORTED EBB FAULT ALARMS, WHICH RESOLVED ON THEIR OWN. ON (B)(6) 2025, AN EBB FAULT ALARM WAS REPORTED TO HAVE OCCURRED 1 WEEK PRIOR. A SELF-TEST WAS COMPLETED IN CLINIC AND THERE WERE NO VISIBLE ALARMS ON THE SYSTEM CONTROLLER. THE MODULAR CABLE APPEARED TO HAVE BEEN COMPLETELY TAPED WITH RESCUE TAPE. IT WAS RECOMMENDED THAT THE PATIENT EXCHANGE BOTH THE CONTROLLER AND THE MODULAR CABLE AT THE SAME TIME. FOLLOWING REVIEW OF THE SUBMITTED LOG FILES BY TECHNICAL SERVICES, IT APPEARED THERE WERE EBB FAULT ALARMS BETWEEN (B)(6) 2025. GIVEN THE ALARMS AND THE STATE OF THE MODULAR CABLE, TECHNICAL SERVICES RECOMMENDED THAT BOTH THE SYSTEM CONTROLLER AND MODULAR CABLE BE REPLACED. THERE ALSO APPEARED TO BE A FEW LOW POWER ADVISORIES DUE TO NORMAL BATTERY DEPLETION WITHIN THE LOG FILES. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY AND THE MECHANICAL CIRCULATORY SUPPORT (MCS) EQUIPMENT OPERATED AS INTENDED. DUE TO THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) BEING LOW, THE PATIENT MISSING MULTIPLE WARFARIN DOSES, AND HAVING NO ACTIVE ALARMS, THE PATIENT WAS SCHEDULED FOR AN EXCHANGE. THE EQUIPMENT WOULD BE RETURNED AFTER THE EXCHANGE. THE MODULAR CABLE AND CONTROLLER WERE BOTH EXCHANGED ON (B)(6) 2025. THE PATIENT DENIED ANY ALARMS FOLLOWING THE EXCHANGE. THE MODULAR CABLE DAMAGE WAS NOTED TO HAVE BREACHED THE ARMOR LAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170489 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8854654 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male