MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531US

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Event Description

It was reported that the patient had changed out their own controller about 2 weeks ago.The change was made due to a small tear in one of the battery cables which compromised the integrity of the internal wires.The patient was provided with a new backup controller.

Event Description

Mpu related mfr #: 2916596-2022-12868.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a tear in the system controller power cable was confirmed via analysis of the returned system controller (serial number: (b)(6) ).Visual inspection of the returned system controller revealed a small tear in the outer jacket of the black power cable, exposing the underlying layers.Additionally, a kink was observed at the location of the tear.A kink was also observed in the white power cable.The returned controller passed functional testing and successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced.The damage to the power cables did not affect the functionality of the controller during testing.Sections of the returned system controller¿s power cables outer jackets were removed near where cables were damaged to inspect the underlying layers.Inspection of the underlying protective layers and shielding revealed that they were in worn condition.The protective layers were then carefully removed to inspect the underlying wires, revealing that all of the wires were kinked.Further inspection of the wires did not reveal any breakdown in the insulation.The downloaded log file contained approximately 11 days of data ((b)(6) 2022 per the timestamp).The data in the log file did not indicate any issues with the system controller.The driveline was disconnected on (b)(6) 2022 at 09:21:25 to exchange the system controller.The pump maintained a speed above the low speed limit while the driveline was connected without issue throughout the log file.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6) , was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the system controller and the power cables.Heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the system controller power cables.This section also explains the importance of protecting the system controller power cables from kinks, sharp bends, and repeated bending.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the system controller power cables for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.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 3 SYSTEM CONTROLLER
• Type of Device: 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: 15079078
• MDR Text Key: 304338475
• Report Number: 2916596-2022-12234
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2024
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8094044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American