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

Model Number 106531INT

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 10/25/2023

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 a defect in the kinking protection on the system controller was noted.An exchange was recommended.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of power cable damage was able to be confirmed.The heartmate 3 system controller (serial number: (b)(6)) was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 7 days (17oct2023 ¿ 24oct2023 per timestamp).There were no notable alarms active in the logfile.Pump operation was not affected, and the device appeared to function as intended.An image of the reported damage was provided.The image showed damage to the white power cable strain relief.There was no damage to the outer silicone layer.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(6)) and was found to pass all manufacturing and qa specifications before being shipped to the customer.Heartmate iii instructions for use (rev.G) section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information was received that the controller was not exchanged.

• 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: 18050257
• MDR Text Key: 327165843
• Report Number: 2916596-2023-07669
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 106531INT
• Device Lot Number: 5936879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 70 KG