MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, POWER MODULE PATIENT CABLE 14V; VENTRICULAR (ASSIST) BYPASS

Model Number	103426
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 complete.
Event or Problem Description
It was reported there were issues connecting the heartmate touch to the blue tooth adapter.The device was not showing up on the heartmate touch when attempting to connect by pressing the grey button on the adapter.The blue tooth adapter was unplugged and plugged back in and then exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
The connectivity issues resulted in a brief delay in ability to start the patient's right heart catheter procedure.The adapter exchange successfully resolved the connectivity issues.The cause was believed to be a bluetooth issue.
Additional Manufacturer Narrative
Corrections: b5, d4, d9, h6.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was later reported on 15jan2026 that the cause of the heartmate touch connectivity issues was identified to be the patient cable between the system controller and power module, not the heartmate touch wireless adapter.
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.Section g3: date received by manufacturer of the previous report was 15jan2026.Manufacturer's investigation conclusion: the reported event of a communication issue was not confirmed.The provided information indicated the wireless adapter was exchanged during troubleshooting; however, the issue was then traced to the patient cable.Multiple attempts were made to obtain additional information regarding the lot number of the patient cable, details of any troubleshooting steps taken, if any equipment was exchanged, and if the patient cable would be returned; however, no additional information has been provided and to date, the patient cable has not been received for further analysis.A root cause for the reported event was not conclusively determined through this analysis.Device history records could not be reviewed due to the lot number of the heartmate power module 14v patient cable not being reported.The current revision of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu, rev.D, heartmate 3 patient handbook, rev.A are currently available.Section 8 of the ifu, entitled ¿equipment storage and care¿, addresses how to properly care for, maintain, and store all equipment for proper use including the power module.Section 4 of the ifu, entitled ¿heartmate touch communication system¿, gives instruction on how to connect to the heartmate touch and how to use the heartmate touch.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®, POWER MODULE PATIENT CABLE 14V
• 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: 23747137
• Report Number: 2916596-2025-07681
• Device Sequence Number: 5928469
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: (01)00813024010784
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2026

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: Health Professional
• Device Model Number: 103426
• Device Catalogue Number: 103426
• Device Lot Number: 8244703
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/08/2025; Not provided; 02/09/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/28/2026; 02/12/2026
• 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 Age: 21 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American