MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	106531US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported the backup system controller issued during implant had a broken screw.The system controller was not used and a different system controller was issued as a backup.Additionally it was reported that there was a broken screw head on the patient's primary system controller when attempting to close cover after inserting the emergency backup battery.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported of a damaged screw for the heartmate 3 system controller (serial number: (b)(6)) was confirmed via submitted photos.The submitted photos revealed a screw for the backup battery cover appeared to be broken.Log files were not submitted for review and product was not returned for testing.Per provided information the controller was exchanged, there was no delay in implant procedure, and the patient did not have any symptoms.The root cause of the reported event could not be conclusively determined through this analysis.A manufacturing analysis has been initiated to further investigate this issue.The device history records were reviewed and the records revealed no deviations from manufacturing and qa specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The abbott heartmate 3 ifu with heartmate touch, rev.B) and abbott heartmate 3 left ventricular assist system (lvas) patient handbook, rev.B) are currently available.Section 5 of the ifu provides instructions for installing the backup battery in the system controller.The patient handbook instructs the user to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
• 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: 24260191
• Report Number: 2916596-2026-00402
• Device Sequence Number: 9649398
• Product Code: DSQ
• UDI-Device Identifier: 05415067039446
• UDI-Public: (01)05415067039446(17)270804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• 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): 02/18/2026

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: Health Professional
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: L00004504
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 76 KG