BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE, INT

    MDR report key: 9202395 · Received October 17, 2019

    Report

    Report Number
    2916596-2019-04700
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 29, 2019
    Report Date
    December 5, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED PHOTO CONFIRMED DAMAGE ON THE PATIENT¿S MODULAR CABLE, LOT NUMBER 162759, TO THE INLINE CONNECTOR BEND RELIEF, AS WELL AS DISCOLORATION OF THE MODULAR CABLE, INLINE CONNECTOR BEND RELIEF, AND CONTROLLER CONNECTOR BEND RELIEF. THE ACCOUNT REPORTED THAT THE PATIENT¿S MODULAR CABLE WAS DAMAGED. THE DAMAGE WAS REPAIRED WITH RESCUE TAPE TEMPORARILY, BUT THE MODULAR CABLE WAS EXCHANGED ON 15 OCT 2019. THE DAMAGED MODULAR CABLE WAS NOT RETURNED FOR EVALUATION. THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. THE HM3 LVAS IFU ALSO EXPLAINS HOW TO REPLACE THE MODULAR CABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S EXTERNAL PERCUTANEOUS LEAD HAD BEEN REPAIRED BY THE APPLICATION AND REINFORCEMENT OF RESCUE TAPE ON MULTIPLE OCCASIONS. THE LVAD PUMP IS FUNCTIONING AS INTENDED WITH NO ABNORMAL ALARMS DETECTED. UPON INSPECTION ON 29SEP2019, THE EXTERNAL SILICONE HOUSING NEAR THE MODULE CABLE CONNECTOR WAS ALMOST DETACHED. RESCUE TAPE WAS RE-APPLIED. THE MODULAR CABLE WAS EXCHANGED ON (B)(6) 2019. THE PATIENT WAS ASYMPTOMATIC WITH NO ISSUES DURING EXCHANGE AND THE MODULAR CABLE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996055 HEARTMATE 3 VAD MODULAR CABLE, INT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525INT 162759

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR