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

Model Number	106762
Medical Device Problem Codes	Mechanical Problem (1384); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a green smudge was noticed on the patient's white power cable.Controller interrogation appeared to capture one low voltage advisory event.The controller has been exchanged and available for evaluation.Log files were sent to tech services for review.Log files contained routine power source changes.No abnormal alarms or events were recorded, and the pump appeared to be operating as intended.The reported green sludge appeared to be cosmetic in nature.
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 green smudge leaking from the white power cable was unable to be confirmed as no images were provided, and the device was not returned for evaluation.Provided information indicated that the cause of the green smudge was not identified.However, the reported information appears consistent with a fluid ingress issue, which has been previously reported under mfr #: 2916596-2025-06401.The controller was exchanged.It was communicated that the exchanged controller would not be returned for evaluation.Review of the submitted log files captured events consistent with routine battery depletion and power source changes.No notable events or alarms were captured, and the system appeared to be operating as intended.A root cause for the reported event could not be conclusively determined.The device history records were reviewed and the records reveal that the heartmate ii system 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 2 of the ifu, ¿system operations¿, and section 2 of the patient handbook, ¿how your heart pump works¿, instruct users to keep their equipment, including the system controller and power cables, away from water or liquid.The ifu and patient handbook also address how to properly care for and maintain the equipment for proper use, including the system controller power cables.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.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23649762
• Report Number: 2916596-2025-07550
• Device Sequence Number: 15926954
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)220411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/05/2026

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: 04/11/2022
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 7008792
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2019
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 86 KG