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

Model Number	106762
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's system controller had aesthetic damage and no alarm.The controller would be exchanged on (b)(6) 2026.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of aesthetic damage to the system controller was unable to be confirmed.According to the account, the cause of the damage was unknown.The heartmate ii system controller (serial number (b)(6)) was not returned for analysis, and no photos of the damage were submitted for review.Provided information indicated that there were no alarms, and there was no concern about a failure to alarm by the controller.A controller exchange was performed, and the exchanged controller was disposed.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed and the records reveal that the heartmate ii pocket controller, serial number (b)(6), was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu),, and the heartmate ii lvas patient handbook,are currently available.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Section 10 of the patient handbook, ¿safety checklists¿ instructs users to regularly inspect their equipment for damage, including damage to the system controller, and to obtain replacements if needed.The patient handbook 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.
Event or Problem Description
The cause of the damage was not available.It was noted that this event did not create any alarms.There was not concern about a failure to alarm by the controller.The controller was exchanged.

• Brand Name: THORATEC® HEARTMATE II®, 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: 24315481
• Report Number: 2916596-2026-00754
• Device Sequence Number: 17359261
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)250208
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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 Expiration Date: 02/08/2025
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 9199742
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2023
• 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: Female
• Patient Weight: 65 KG