MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2465
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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 that two batteries were exchanged due to corrosion on the contacts that corroded the metal.
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 later reported that the cause of the corrosion was unknown.The patient also did not experience any adverse events due to the corrosion.
Additional Manufacturer Narrative
D6a - date of implant was inadvertently added in the initial report and is not applicable to this device.Manufacturer¿s investigation conclusion: the reported event of corrosion on the 14v battery contacts was confirmed via analysis of the returned heartmate 14 volt li-ion battery (serial number (b)(6)).Visual inspection of the battery revealed a black residue consistent with corrosion on the positive voltage metal contacts.The returned battery was functionally tested and found to operate as intended during testing.The battery was connected to a test system controller, a test battery clip, and a mock circulatory loop, and the battery supported the system without any issues or atypical alarms produced, including when the battery was manipulated by hand within the battery clip.The returned battery was also inserted in a test universal battery charger multiple times and each time the battery accepted for charge with no faults active.The root cause of the reported event could not be conclusively determined through this analysis.Battery inspection data was reviewed for the 14v battery, serial number (b)(6), revealing that the battery passed all inspection testing.The 14v battery was inspected on 29oct2024 per material document.The battery was shipped to the customer on 20jan2025.The current revision of the instructions for use (ifu) can be found on the electronic ifu page of the abbott website.Heartmate 14 volt li-ion battery instructions for use (rev.E) explains the operation of batteries in the heartmate system.Heartmate 3 patient handbook (rev.A) section 6 ¿ "caring for the equipment" and heartmate 3 instructions for use (rev.D) section 8 ¿ ¿equipment storage and care¿ describe how to care for and clean all equipment, including the 14v batteries.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and auditory), including battery faults displayed on the universal battery charger and the actions to take if the issue does not resolve.The patient handbook and the instructions for use 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.

• Brand Name: HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET
• 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: 23319917
• Report Number: 2916596-2025-06800
• Device Sequence Number: 4838677
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(17)271015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/18/2025

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: Health Professional
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: SY289-B137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 11/13/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/03/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic
• Patient Race: White