BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 8300640 · Received February 4, 2019

    Report

    Report Number
    2916596-2019-00543
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    October 20, 2018
    Report Date
    March 14, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 1 YEAR AND 1 MONTH. DEVICE EVALUATION: THE REPORTED EVENT OF A DAMAGED MODULAR CABLE WAS VISUALLY CONFIRMED. THE RETURNED MODULAR CABLE, LOT# 190296, WAS TESTED TOGETHER WITH LABORATORY TEST EQUIPMENT AND THE SYSTEM FUNCTIONED WITHOUT ANY ALARMS ACTIVE. THE MODULAR CABLE WAS FUNCTIONALLY TESTED PER THE MODULAR CABLE TEST PROCEDURE TO EVALUATE THE INTEGRITY OF ITS WIRES; THE MODULAR CABLE FAILED TO PASS THE TEST. THE RETRIEVED LOG FILE (FROM THE RETURNED SYSTEM CONTROLLER: HSC-(B)(4)) CONTAINED APPROXIMATELY 28 DAYS OF DATA (DATED: 15OCT2018 ¿ 12NOV2018, PER THE TIME STAMP). THE STORED PATIENT SPEED WAS SET TO 5600 RPM AND THE LOW SPEED LIMIT (LSL) WAS SET TO 5400 RPM. THE PUMP MAINTAINED A SPEED ABOVE THE LSL WITHOUT ISSUE WHILE THE DRIVELINE WAS CONNECTED. EVALUATION OF THE LOG FILE DID NOT INDICATE AN ISSUE WITH THE CONNECTED LVAD MODULAR CABLE; THE PUMP APPEARED TO BE MAINTAINING WITHIN PUMP PARAMETERS AS INTENDED WHILE THE DRIVELINE IS CONNECTED. EVALUATION OF THE RETURNED MODULAR CABLE REVEALED SEVERAL DAMAGED AREAS ON THE OUTER INSULATION OF THE CABLE. THE SILICONE JACKET OF THE MODULAR CABLE WAS STRIPPED TO INSPECT THE INTERNAL WIRES. THE ARMOR LAYER WAS REMOVED AND SEVERAL KINKED WIRES WERE NOTED. THE DAMAGE DID FULLY PENETRATE THE OUTER JACKET, HOWEVER, NO WIRES WERE EXPOSED NOR BROKEN, ONLY KINKED AREAS WERE NOTED. THE PROVIDED INFORMATION INDICATED THAT THE ROOT CAUSE FOR THE DAMAGE TO THE MODULAR CABLE WAS DUE TO THE REPORTED ANIMAL BITES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT UPON THE HEALTHCARE PROFESSIONAL¿S PHYSICAL EXAMINATION OF THE MODULAR CABLE, BITE MARK DAMAGE THROUGH THE MODULAR CABLE WAS NOTED. THERE WERE MULTIPLE SPOTS WHERE REPORTEDLY THE OUTER LAYER WAS CRACKED AND OPEN. THE PATIENT STATED THAT THE CAT CHEWED ON THE CABLES. THE EVENT REPORTEDLY DID NOT HAVE AN EFFECT ON PATIENT. THERE WAS NO INTERRUPTION TO PUMP SUPPORT. THE MODULAR CABLE WAS REPLACED. INVESTIGATION OF THE RETURNED MODULAR CABLE BY THE MANUFACTURER REVEALED WIRE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94285 HEARTMATE 3 VAD MODULAR CABLE LVAD MODULAR CABLE DSQ THORATEC CORPORATION 106525 190296 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR