MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP; Ventricular (assist) bypass

Model Number	103696
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the system controller was returned for evaluation following the patient's death; no issues regarding the controller were reported.The returned system controller (serial number (b)(6) was functionally tested and was found to perform as intended.The provided log file was reviewed, and the pump operated at intended speeds throughout the data.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate ii lvas patient handbook (rev.D, section titled ¿important warnings¿) instructs users to never submerge their equipment, including the system controller, into water or liquid or other materials.The heartmate ii lvas patient handbook (rev.D, section titled ¿list of emergency contacts¿) instructs users to call their hospital contact at any time in the event that they think or feel their pump is not operating as intended.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that investigation of the returned system controller revealed contamination of a foreign material around the driveline release button and latch and wire fatigue within both power cables that did not affect the system controller¿s functionality throughout testing.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• 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: 21413741
• Report Number: 2916596-2025-00757
• Device Sequence Number: 8214493
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)10312020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 10/31/2020
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2017
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG