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

Model Number	106525US
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of driveline power fault alarms was confirmed via the submitted log files.No photos of the modular cable were submitted for review, and no product was returned for further analysis.Submitted log files indicate driveline power fault alarm on (b)(6)2026.Provided information indicates both the system controller and modular cable were exchanged after substitutes were located.No further alarms were observed in log files post system controller and modular cable exchange.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause of the reported event could not be determined through this analysis.No lot number was provided by the customer to perform a device history record review.The current revision of the instructions for use (ifu) and patient handbook (phb) can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu heartmate 3 phb are currently available.Section 7 of the ifu, entitled ¿alarms and troubleshooting¿, provides instruction on how to identify and troubleshoot driveline power fault alarms.Section 5 of the ifu, entitled ¿surgical procedures¿ and section 6, entitled ¿patient care and management¿ caution user to avoid twists, kinks, or sharp bends in the driveline.Section f of the ifu, entitled ¿safety checklists¿ instructs users to inspect the driveline for damage daily.The patient handbook which was available for use at the time of the event, cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• 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 ; +1(781)852-8207
• MDR Report Key: 50457050
• Report Number: 2916596-2026-2919229
• Device Sequence Number: 10377243
• Product Code: DSQ
• UDI-Device Identifier: 00813024013181
• UDI-Public: (01)00813024013181
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 206 LB
• Patient Race: White