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

Model Number	103696
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced driveline disconnection.The issue was caused by the patient's failure to comply with rules for maintenance and protection of the device and loss of power supply due to capsule damage.On (b)(6) 2024 the patient underwent a pump exchange surgery from a heartmate ii to a heartmate 3 for possible driveline damage.Pump mfr # 2916596-2024-00403.
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
Additional information was received that the cause of the driveline disconnect was unknown.The patient had a short-to-shield due to a damage to a layer of the driveline peculiar to the heartmate ii.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a pump stop event was confirmed; however, the system controller was determined to have been unrelated to the cause of the event.The returned system controller (serial number (b)(6) was functionally tested and was found to perform as intended.A log file was extracted from the controller during testing, and no atypical events regarding the controller were observed.Per additional information, the patient underwent an hm2 to hm3 pump exchange to resolve the issue.The root cause for the reported event was determined to be related to the driveline of the pump and will be addressed via the returned hm2 pump¿s investigation.The system controller was not correlated to the root cause of the reported event.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 ¿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.

• 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: 18813136
• Report Number: 2916596-2024-01247
• Device Sequence Number: 19919180
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)191231
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 12/31/2019
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 6125191
• 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: 02/11/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 63 KG