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

Model Number	106762
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient's backup system controller had to be changed due to damage to the white cord.Log files were unable to be pulled as it could not be connected.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of white power cable damage on the system controller was not confirmed.There were no photos or log files of this primary controller submitted for review.System controller was not returned for analysis.The provided information stated that the controller was exchanged due to the white power cord being damaged.The log file was unable to be pulled as it couldn't be connected.The log file from the new primary controller was submitted to make sure the controller was working correctly.Additional information provided stated that the serial number and photos of the system controller was not available, and the controller would not be returned.A root cause for the reported event cannot be conclusively determined through this analysis.Device history records could not be reviewed due to the serial number of the system controller being unavailable.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.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot all alarms.Heartmate ii instructions for use section 8-¿equipment storage and care¿ and heartmate ii patient handbook section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information was provided.The manufacturer is closing the file on this event.

• 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: 24137945
• Report Number: 2916596-2026-00301
• Device Sequence Number: 5370757
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: 106762
• Device Catalogue Number: 106762
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/02/2026
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG