BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19351880 · Received May 20, 2024

    Report

    Report Number
    2916596-2024-03063
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 22, 2024
    Report Date
    July 15, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED DAMAGE TO THE MODULAR CABLE INLINE CONNECTOR PIN WAS CONFIRMED THROUGH EVALUATION OF THE RETURNED PRODUCT. THE HEARTMATE 3 MODULAR CABLE WAS RETURNED IN USED CONDITION WITH THE OUTER JACKET AND BEND RELIEFS SHOWING GRAY DISCOLORATION. VISUAL INSPECTION OF THE INLINE CONNECTOR REVEALED THAT ONE OF THE PINS WAS SLIGHTLY BENT. THE MODULAR CABLE WAS CONNECTED TO A TEST FIXTURE FOR FUNCTIONAL TESTING AND NO DIFFICULTY WAS ENCOUNTERED WHILE MAKING THE INLINE CONNECTION. THE MODULAR CABLE PASSED TESTING WITHOUT ISSUE. ALTHOUGH A BENT PIN IN THE INLINE CONNECTOR WAS CONFIRMED, THE REPORTED DIFFICULTY IN MAKING THE INLINE CONNECTION WAS NOT REPRODUCED. THE CAUSE OF THE BENT PIN COULD NOT BE CONCLUSIVELY DETERMINED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR MODULAR CABLE, LOT NUMBER 8240775 WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU IS CURRENTLY AVAILABLE. SECTION 5 OF THIS IFU OUTLINES THE STEPS FOR CONNECTING THE PUMP AND MODULAR CABLES. THE IFU ALSO WARNS THAT A COMPLETE BACKUP SYSTEM MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. THE SECTION ¿PATIENT CARE AND MANAGEMENT¿ INFORMS THE USER ¿IF THE DRIVELINE OR MODULAR INLINE CONNECTOR APPEARS DAMAGED, PLEASE CONTACT THORATEC CORPORATION FOR ASSISTANCE¿. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. SECTION 4 "LIVING WITH THE HEARTMATE III" (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. 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.". 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 COMPLETE.

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME: CORRECTED. D4: CATALOG NUMBER AND UDI: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A DRIVELINE INFECTION RETURNED TO THE OPERATING ROOM (OR) FOR RELOCATION OF THE EXIT SITE AND INCISION AND DRAINAGE OF THE INFECTED SITE. AFTER TUNNELING THE DRIVELINE TO THE NEW EXIT SITE, THE SURGEON COULD NOT GET THE MODULAR CABLE RECONNECTED TO THE PUMP CABLE. CARDIOPULMONARY RESUSCITATION (CPR) COMPRESSIONS WERE NECESSARY DUE TO LOW BLOOD PRESSURE WHILE ANOTHER MODULAR CABLE WAS OPENED AND MADE AVAILABLE. THE NEW MODULAR CABLE WAS CONNECTED UPON THE FIRST ATTEMPT AND THE VENTRICULAR ASSIST DEVICE (VAD) WAS RESTARTED. THE PATIENT BECAME HEMODYNAMICALLY STABLE IMMEDIATELY AFTER THE VAD WAS RESTARTED AND CPR WAS NO LONGER NECESSARY. THE PATIENT RECOVERED AND WAS DISCHARGED WITHOUT ANY LONG-TERM ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS ADMINISTERED ANTIBIOTICS, AND THE PREVIOUS DRIVELINE SITE WAS PACKED WITH IODOFORM. IT WAS NOTED THAT THE MODULAR CABLE THAT WAS EXCHANGED HAD A BENT PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860862 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8240775 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention