MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	106128
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
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 a tear in bend relief was noted with no wires exposed or alarms.This was on the distal end of the driveline to the system controller.There was no evidence of any type of driveline electrical conductor issue in the log file.The tear to the percutaneous lead outer jacket appeared cosmetic only.It was also noted possible green substance (corrosion) or possible water damage in the controller.The controller was operating normally.Additional information stated that rescue tape was applied to the damaged driveline.The controller was exchanged due to water damage present on the screen and corrosion of internal 11-volt battery.Related driveline damage is reported under manufacturer report number 2916596-2024-01343.Related controller is reported under manufacturer report number 2916596-2024-01344.
Additional Manufacturer Narrative
Section d1: corrected.Section d4: corrected.Manufacturer's investigation conclusion: the reported event of fluid on the 11v backup battery (serial number: (b)(6)) was able to be confirmed by the submitted photo.Evaluation of the photo revealed fluid ingress within the backup battery compartment and on the backup battery itself.Provided information indicated that the controller was still operating normally.A log file was also submitted for review, which contained information spanning approximately 5 hours on (b)(6) 2024 (9:08:58 to 13:41:25 per timestamp).No notable events or alarms were observed, and the pump maintained within the expected speed range without issue.The backup battery was not in use throughout the data.Provided information indicated that the system controller and its backup battery were exchanged in response to the observed fluid ingress; the products did not return to abbott for further analysis.The root cause of the fluid ingress could not be conclusively determined through this analysis.The device history records showed that the system controller was manufactured in accordance with manufacturing and quality assurance specifications.This controller was originally packaged with backup battery (b)(6).The initial inspection records were reviewed for the backup battery, and it was found to pass all tests.Heartmate ii patient handbook (rev.C) section 5, entitled ¿alarms and troubleshooting¿, and heartmate ii instructions for use (ifu) (rev.C) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible) and the actions to take if the alarms cannot be resolved.The heartmate ii patient handbook (rev.C) instructs users to never submerge their equipment, including their system controller, underwater.The patient handbook also instructs users to never expose their equipment to liquids or fluids of any kind.Heartmate ii patient handbook (rev.C) section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system controller.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate ii lvad.The heartmate ii lvas ifu (rev.C) and heartmate ii patient handbook (rev.C) both caution 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: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY
• 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: 18935736
• Report Number: 2916596-2024-01736
• Device Sequence Number: 12484365
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)240817
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 08/17/2024
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 8121600
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 121 KG