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

Model Number 106531INT

Device Problem Material Deformation (2976)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

It was reported that during the transport of the patient the system controller was damaged at the black connector cable.The vad coordinator exchanged the patient's controller.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage to the black cable¿s connector nut was confirmed during evaluation of the returned heartmate 3 system controller (serial number: (b)(6).The controller¿s black power cable was still able to connect and partially lock into multiple power sources despite the observed damage.The controller was functionally tested and found to perform as intended.Additionally, a log file containing approximately 4 days of data (04apr2022 to 08apr2022 per timestamp) was downloaded for review, and no atypical events were observed.The root cause of the reported damage was unable to be conclusively determined through this analysis.Review of the device history record for the heartmate 3 system controller, serial number (b)(6), showed that the device was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook section 6 "equipment maintenance", describes how to care for and clean all equipment, including the system controller and its 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.The patient handbook also 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.

• 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: 14211778
• MDR Text Key: 290102865
• Report Number: 2916596-2022-10339
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 106531INT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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