BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18383838 · Received December 22, 2023

    Report

    Report Number
    2916596-2023-08646
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 30, 2022
    Report Date
    June 5, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT INFORMATION WAS NOT PROVIDED, REQUEST FOR THIS INFORMATION HAS BEEN MADE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    VOLUNTARY MEDWATCH NUMBER 3400300000-2022-0000048 WAS RECEIVED ON 08DEC2023. ADDITIONAL VOLUNTARY MEDWATCH NUMBER 3400300000-2022-0000057 FOR THIS EVENT WAS RECEIVED 11JAN2024. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF DAMAGE TO THE MODULAR CABLE WAS NOT CONFIRMED AS NO PHOTOS WERE SUBMITTED AND THE CABLE WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE PATIENT HAD DISREPAIR TO THEIR MODULAR CABLE WHICH REQUIRED IT TO BE EXCHANGED. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION, INCLUDING PRODUCT RETURN STATUS, WERE SENT TO THE CUSTOMER; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 2 OF THIS IFU EXPLAINS HOW TO REPLACE THE MODULAR CABLE. SECTION 6 OF THIS DOCUMENT CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS IFU FURTHER EMPHASIZES NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, OR MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF THE EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE PUMP TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN. SECTION 6 (UNDER "CARING FOR THE DRIVELINE") ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7 OF THIS IFU PROVIDES ADDITIONAL INSTRUCTION REGARDING THE DRIVELINE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." FINALLY, SECTION 8 EXPLAINS THAT AS NEEDED, THE USER CAN CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, ALSO CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE, INCLUDING A SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D1 BRAND NAME: CORRECTED; SECTION D4 MODEL NUMBER: CORRECTED; SECTION D4 CATALOG NUMBER: CORRECTED; SECTION D4 PRIMARY UDI NUMBER: CORRECTED; SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS IN CLINIC (B)(6) 2022 NOTED TO HAVE DISREPAIR TO MODULAR PORTION OF DRIVELINE. MODULAR CABLE WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373851 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male