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 07/19/2022

Event Type  malfunction  

Event Description

It was reported that there was a cut in the system controller power lead during clinic visit that exposed the inner wires.There were no alarms noted.An echocardiogram was performed and the controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage on the white power cable was confirmed via evaluation of the returned heartmate 3 system controller (serial number: (b)(4)).Visual inspection of the returned controller revealed cuts at approximately 3.5 inches from the controller strain relief on the superficial jacket of the white power cable.The shielding was exposed from the cuts; however, no exposed conductors were observed.No other physical anomalies were noted.The returned system 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 system controller passed functional testing without any issues.The observed damage did not affect the functionality of the system controller.The integrity of the white power cable wires was tested and no issues were observed.The superficial jacket of the white power cable was removed and the cable shielding was also observed to be torn below the damage; there were exposed conductors on the tear.The cable shielding was then removed and no physical damage was observed on the underlying wires.No other issues were observed.The submitted log file contained approximately 15.5 hours of data ((b)(6) 2022 at 22:52:10 ¿ (b)(6) 2022 at 14:18:27 per the timestamp).The log file did not capture any issues on the controller.There were no notable alarms throughout the log file.The driveline was disconnected on (b)(6) 2022 at 14:17:54 to exchange the system controller.The pump maintained a speed above the low speed limit while the driveline was connected.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)(4), was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on 07apr2022.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 (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: 15128783
• MDR Text Key: 304620673
• Report Number: 2916596-2022-12440
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2022

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 Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8390035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG