MAUDE Adverse Event Report: Thoratec Corporation Thoratec® HeartMate 3¿ VAD Modular Cable; Ventricular (Assist) Bypass

Model Number	106525US
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a driveline communication fault alarm and presented to the clinic for evaluation.The modular cable was exchanged, which the patient tolerated without issue.Log files were obtained before the exchange.The log file captured driveline communication fault alarms beginning at 5:55 am the morning of (b)(6) 2026.The system continued to operate at the set speed and was supported by the controller¿s backup battery until external power was restored.There were no other unusual events recorded in the log file event history.The mechanical circulatory support (mcs) equipment was operating as intended.The alarm resolved after the modular cable was exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: Thoratec® 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 ; +1(781)852-8207
• MDR Report Key: 50899553
• Report Number: 2916596-2026-2919893
• Device Sequence Number: 20290895
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181(10)10184799(17)270207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/25/2026

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
• Device Lot Number: 10184799
• Was Device Available for Evaluation?: No
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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: 75 YR
• Patient Sex: Unknown
• Patient Race: White