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

Model Number	103696
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of wire fatigue was confirmed.The heartmate ii system controller, ep (serial number: (b)(6) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed 120 events spanning approximately 6 days (days 1506 hours 17 minutes 22¿ days 1511 hours 16 minutes 38, days 0 hours 0 minutes 0 per time stamp).Events occurring on days 0 hours 0 minutes 0 were recorded during testing at abbott.The pump was disconnected on days 1511 hours 16 minutes 38 for a routine transplant.There were no notable alarms active in the log file that would indicate an issue with the system controller.The returned system controller was functionally tested.The controller was unable to pass all testing due to slightly raised resistances within the white power cable.An insulation test was performed on the white power cable, and it passed without any issues.The resistance of the underlying wires within the cable was measured and raised resistances were found in the brown, clear, blue, orange, and red wires.These resistances fluctuated upon manipulation.The cable was stripped of its outer jacket; however, no damage was observed to the underlying wires indicating that the breakdown was only to the inner conductors within the wires.The system controller was run on a mock loop and was able to support pump function for an extended duration without any issues or alarms activating.A root cause for the reported event was unable to be conclusively determined.Heartmate ii instructions for use section 21.0 entitled ¿inspection, cleaning, and maintenance guidelines¿ details how to properly care for, maintain, and store the equipment for proper use.Heartmate ii instructions for use section 3 entitled ¿powering the system¿ and heartmate ii patient handbook rev.D section 3 entitled ¿powering the system¿ instructs the user not to bend, twist, or kink the power leads of the system controller and addresses how long the 14v batteries provide power to the system controller.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.The device history records were reviewed and the records revealed the heartmate ii system controller, ep (serial number: (b)(6) was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that following the patient's heart transplant the system controller was found to have wire fatigue.

• Brand Name: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16598576
• Report Number: 2916596-2023-01695
• Device Sequence Number: 5310674
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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: 02/28/2021
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 6343635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• 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: 03/20/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 51 KG