MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 VAD MODULAR CABLE; Ventricular (assist) bypass

Model Number	106525US
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of driveline communication fault alarms occurring on the modular cable (lot number 9025513) was confirmed via log file analysis.Log file analysis revealed driveline communication fault alarms that were associated with comm a line faults beginning from (b)(6) 2025; however, pump function was not interrupted during these events.These alarms persisted until the system controller and modular cable were exchanged on (b)(6) 2025.No other notable events or alarms were captured, and the pump appeared to function as intended at the fixed speed.The returned modular cable was functionally tested with the returned system controller on a mock circulatory loop.The modular cable operated as intended throughout testing, and the reported driveline communication fault alarm could not be reproduced.The layers of the modular cable were then removed one at a time to inspect the underlying wires, and no damage was found that would have contributed to the reported alarms.Incidental finding: wire fatigue.The root cause of the reported event was unable to be conclusively determined through this investigation.The relevant sections of the device history records for the modular cable (lot number 9025513) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist device (lvas) instructions for use (ifu) and the heartmate 3 patient handbook are currently available.The current revision of ifu and patient handbook can be found on the eifu page of the abbott website.Heartmate 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot driveline fault alarms.The heartmate 3 instructions for use, section 5, entitled ¿surgical procedures¿ and section 6, entitled ¿patient care and management¿ caution user to avoid twists, kinks, or sharp bends in the driveline.The heartmate 3 instructions for use, section d, entitled ¿safety checklists¿ instructs users to inspect the driveline for damage daily.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that log files were submitted for the patient along with x-rays.The patient had presented to the emergency room (er) after their system controller alarmed for driveline communication fault and was asymptomatic prior to and after arrival.It was noted there was a lot of rescue tape on the proximal external part of the driveline, and some twisting with a small defect in the modular cable section.The log files captured driveline communication a fault alarms on (b)(6) 2025.It was recommended to exchange the modular cable and system controller and to perform 15 power cable disconnect alarms so that new log file data can be recorded and reviewed.The reported alarm did not interfere with pump operation, and the x-ray images were unremarkable.Additional log files were submitted after controller and modular cable were exchanged as suggested which showed the alarm did not recur.The submitted photo of the connector also looked good with no additional action needed in response.There was no adverse impact to the patient.

• Brand Name: HEARTMATE 3 VAD MODULAR CABLE
• Common Device Name: Ventricular (assist) bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24211150
• Report Number: 2916596-2026-00671
• Device Sequence Number: 5495135
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 106525US
• Device Catalogue Number: 106525US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 85 KG