MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® POWER MODULE (N/A); VENTRICULAR (ASSIST) BYPASS

Model Number	1340
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
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
It was reported that the power module battery clip broke and needed the streamline cable to repair the unit.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a damage streamline cable on the power module (b)(6) was unable to be confirmed.Photos of the damage were not submitted and product was not returned for testing.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.A root cause for the reported event could not be conclusively determined through this investigation.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.Heartmate 3 instructions for use section 4- ¿system monitor¿ and heartmate 3 patient handbook section 6- ¿caring for the equipment¿ explain how to properly handle the power module and cables to prevent damage.Heartmate 3 instructions for use section 7- ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5- ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot atypical alarms.The device history records were reviewed and the records revealed no deviations from manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE® POWER MODULE (N/A)
• 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: 23397303
• Report Number: 2916596-2025-06776
• Device Sequence Number: 10015342
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654(10)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Model Number: 1340
• Device Catalogue Number: 1340
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown