BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 19659986 · Received July 2, 2024

    Report

    Report Number
    2916596-2024-04351
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    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

    (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D4, PRIMARY UDI NUMBER: CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED IMAGES CONFIRMED THE REPORT OF SUPERFICIAL PUMP CABLE DAMAGE; HOWEVER, A SPECIFIC CAUSE FOR THE REPORTED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE SUBMITTED PHOTOGRAPHS FOUND A SMALL SECTION OF THE PUMP CABLE COVERED WITH RESCUE TAPE. SMALL AREAS OF SUPERFICIAL DAMAGE TO THE OUTER JACKET WERE OBSERVED BENEATH A TEAR IN THE RESCUE TAPE AND BETWEEN THE RESCUE TAPE AND THE PUMP CABLE INLINE CONNECTOR BEND RELIEF. THE OBSERVED DAMAGE DID NOT FULLY PENETRATE THE OUTER JACKET, AND THERE WAS NO EVIDENCE OF EXPOSURE OF THE UNDER LYING ARMOR LAYER. ONE PHOTO SHOWED THAT NEW RESCUE TAPE WAS APPLIED THAT COVERED BOTH AREAS OF SUPERFICIAL DAMAGE. NO WIRES WERE EXPOSED, AND THE DAMAGE APPEARED TO BE COSMETIC IN NATURE. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-023597, WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-023597 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. G, ARE CURRENTLY AVAILABLE. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: ¿DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND URGES PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 7, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿. SECTION 8, ¿EQUIPMENT STORAGE AND CARE¿, ALSO CONTAINS INFORMATION ON ¿CARE OF THE DRIVELINE,¿ AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE. IN THE PATIENT HANDBOOK, SECTION 4, ¿LIVING WITH THE HEARTMATE 3¿, CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DRIVELINE WAS CUT AND A DRIVELINE REPAIR WAS PERFORMED BY A HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WERE NO ALARMS NOTED. NO LOG FILES WERE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552038 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 7829858

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown