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.
Additional Manufacturer Narrative
Section d6a: date of implant was inadvertently populated in the initial report; the device is not implanted.Manufacturer's investigation conclusion: the reported event of the system controller having a damaged screw was confirmed, as the returned system controller (serial number (b)(6)) was observed to have a broken backup battery cover screw upon arrival.The head of the screw was observed to have been severed, leaving the body of the screw stuck in the threading.The controller was functionally tested and operated as intended despite the damaged screw.A manufacturing analysis task was created under a separate event to investigate the root cause of the controller¿s backup battery cover screw becoming broken out-of-box.The device history records were reviewed and the records revealed no deviations from manufacturing and qa specifications.The heartmate 3 patient handbook, section 10 ¿safety checklists¿) and the heartmate 3 lvas instructions for use, section f ¿safety checklists¿) instructs users to regularly inspect their equipment, including their system controllers, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook, section titled "emergency contact list") cautions 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.The current revisions of the patient handbook and instructions for use (ifu) can be found on the eifu page of the abbott website.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: 24260128
• Report Number: 2916596-2026-00401
• Device Sequence Number: 13174031
• Product Code: DSQ
• UDI-Device Identifier: 05415067039446
• UDI-Public: (01)05415067039446(17)270729
• 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
• Device Implanted Year: 2026
• 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: L00004596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• 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: 01/14/2026
• 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): Yes
• Date Device Manufactured: 10/09/2025
• 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