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

Model Number	103696
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.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 patient had green drainage from the cable which connects from power to the driveline.The patient went to the emergency department, where a system controller exchange was attempted, however the red button to release the driveline was stuck.Despite attempting to manipulate the system controller and increase pressure, the site was unable to perform a system controller exchange.Log file review was requested which showed no unusual events.On (b)(6) 2025, the system controller was disassembled in order to access the locking mechanism.The driveline grommet was removed to better apply alcohol to loosen up the driveline connector.The driveline was removed and reconnected to a new system controller.The pump resumed normal operation.There was no adverse patient impact due to this event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported events of green fluid on the power cables, and the driveline¿s release button being difficult to engage, were confirmed via evaluation of the returned system controller (serial number: (b)(6).A small puncture was observed on the black power cable¿s outer jacket with traces of fluid around it underneath a taped area.The returned system controller underwent functional testing and operated a mock loop as intended despite the fluid ingress.The system controller was connected to a mock circulatory loop and operated the system as expected for an extended period of time.The observed fluid ingress did not affect the functionality of the system controller.Following functional testing, the cable jackets were stripped, and fluid ingress was observed throughout both cables.The small puncture in the black cable could have allowed fluid to accumulate within the cables and system controller.Additionally, extensive fluid ingress was observed within the system controller¿s subassembly components, including the bulkhead connector of the system controller.Fluid ingress within the bulkhead of the controller was consistent with the reported difficulty disconnecting the driveline from the controller.The root cause of the driveline¿s release button being difficult to engage was determined to correlate to fluid ingress within the controller.However, the root causes of the fluid ingress within the system controller, or the damage to the black power cable which could have allowed fluid to accumulate, were unable to be conclusively determined through this analysis.The patient remains ongoing on heartmate left ventricular assist system (lvas) support with no further issues reported.Additionally, during investigation damaged bend reliefs of both power cables was found the device history records were reviewed for the system controller (serial number: (b)(6) and found to have passed all manufacturing and qa specifications.The heartmate ii patient handbook instructs users to never submerge their equipment, including their system controller, underwater.The patient handbook also instructs users to never expose their equipment to liquids or fluids of any kind.The heartmate ii patient handbook section 10 ¿safety checklists¿ instructs users to regularly inspect their equipment for damage, and to obtain replacements if needed.The patient handbook 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 device history records were reviewed for the system controller (serial number: (b)(6) and found to have passed all manufacturing and qa specifications.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: 23745086
• Report Number: 2916596-2025-07534
• Device Sequence Number: 12876750
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(10)7853323(17)231206
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 12/06/2023
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 7853323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2020
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG