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

Model Number 106531

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

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

Event Date 10/07/2021

Event Type  malfunction  

Event Description

It was reported that during a clinic follow-up visit, the patient had a cracked white power cable/ connector with green substance leaking out.The patient had their system controller exchanged without issue.

Manufacturer Narrative

Patient age requested, awaiting response.Patient weight requested, awaiting response.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Implant date was inadvertently added in initial report.As the product involved is a controller, there is no implant date.Patient age requested, no response received.Patient weight requested, no response received.Manufacturer's investigation conclusion: the reported event of a damaged strain relief and evidence of fluid ingress was confirmed.Initial inspection of the returned hm3 system controller, serial (b)(6), revealed a damaged strain relief near the white connector and evidence of fluid ingress near the damaged strain relief as well as inside the controller.The controller was functionally tested and operated on a mock circulatory loop for an extended period of time without any issue.The controller functioned as intended during the analysis.A root cause of the reported event was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on (b)(6) 2016.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.Heartmate 3 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.According to heartmate 3 instructions for use ¿replace any equipment or system component that appears damaged or worn¿.Heartmate iii instructions for use section-¿equipment storage and care¿ and heartmate iii patient handbook section-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information 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: 12754653
• MDR Text Key: 280450978
• Report Number: 2916596-2021-06036
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 813024013235
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 106531
• Device Lot Number: 5737219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2016
• 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 Sex: Male