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

Model Number 106531US

Device Problem Material Deformation (2976)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

Patient gender was requested, but not provided.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient came to clinic on (b)(6) 2021 with visible damage and exposed wires on their white power cable, as well as notable kinks on their modular cable.The site exchanged both the modular cable and controller without issue.There were no alarms associated with this event.

Manufacturer Narrative

Section a3: patient gender was requested but not provided.Manufacturer's investigation conclusion: the reported event of damage and exposed wires on the white power cable was confirmed via inspection of the submitted pictures.Visual inspection of the submitted pictures revealed a tear on the white power cable jacket near the power cable connector; the underlying wires of the white power cable were exposed under the tear.Multiple requests for additional information were made to determine if the heartmate 3 system controller (serial number: (b)(6)) would be returned for evaluation; however, no response was received.It was reported that the controller was exchanged without issue and that there were no alarms associated with this event.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 (b)(6) was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on 07apr2019.Heartmate 3 instructions for use section 8, entitled ¿equipment storage and care¿, and heartmate 3 patient handbook section 6, entitled ¿caring for equipment¿, explain how to properly care for the equipment, including the controller and the power cables.Heartmate 3 patient handbook 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 heartmate 3 patient handbook cautions 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 (ASSISST) 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: 13191890
• MDR Text Key: 286757786
• Report Number: 2916596-2021-07605
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6890839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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: 57 YR
• Patient Weight: 116 KG