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 05/10/2022

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 requested a new heartmate 3 system controller.The patient's primary controller developed a tear in the silicon of the white power lead, exposing the blue and orange internal wires.The controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a tear on the silicone jacket of the white power cable was confirmed.Visual inspection of the returned heartmate 3 system controller, serial (b)(6), revealed a tear on the silicone jacket of the white power cable exposing the internal wires.The jacket was removed revealing the underlying wires were kinked but no damage was observed.The controller was functionally tested and passed all steps without any issue.The controller operated on a mock circulatory loop for an extended period of time without reproducing any alarms.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 quality assurance specifications.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 iii instructions for use section 8-¿equipment storage and care¿ and heartmate iii patient handbook section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.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: 14471524
• MDR Text Key: 292397677
• Report Number: 2916596-2022-10969
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8056856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 76 KG