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

Model Number	106762
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system controller ¿shorting¿ was unable to be confirmed.Review of the log files revealed driveline fault alarms from (b)(6) 2025 ¿ (b)(6) 2026.The driveline fault alarms have been addressed under the pump investigation.The rest of the captured data appeared to show the system controller operating as intended.The returned heartmate ii system controller (serial number (b)(6)) underwent functional testing and passed all tests without issue.The controller successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced.The root cause for how the controller shorted was unable to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate ii ifu section 7 ¿ ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual) and the actions to take if the issue does not resolve.The patient handbook and the ifu caution the user 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
It was reported that the patient continued to have alarms noted in their history, but no audible alarms at home.Log files were sent for review.The log captured 157 driveline fault alarms between on (b)(6) 2025 and on (b)(6) 2026.The black wire appeared to be partially damaged.X-ray images showed a few suspect areas.There appeared to be some thinning and/or bends in the driveline.The driveline was repaired.There were no active alarms at time of repair.Visual inspection noted compression and bending of the driveline near the exit site, as well as rescue tape covering the full length of the driveline.Tech services removed remaining outer layer and bionate.The shielding was completely oxidized and fell off immediately after removing bionate.Broken black wire was discovered approximately 3" from exit site.There was noted damage to green wire as well in the same area.Black, red, and yellow wires were spliced.During splicing of yellow wire, green wire broke and shorted the system controller.The patient remained stable.They were swapped over to new driveline and backup controller.Tech services continued splicing green, brown, and orange wires.The area was closed up per procedure, and the patient was provided with care instructions.
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 once the manufacturer¿s investigation is complete.

• 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: 24092762
• Report Number: 2916596-2026-00351
• Device Sequence Number: 10259076
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)260623
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/27/2026

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: 06/23/2026
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 10517043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/02/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 116 KG