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

Model Number 106531US

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damaged strain reliefs was unable to be confirmed.The heartmate 3 system controller (serial number: (b)(4) was not returned for analysis.A log file was submitted for review; however, the log file was not associated with this event and was from a different controller.Multiple good faith effort attempts were made requesting log files from the second controller, and if any product will be returning; however, no response was received.The device history records were reviewed for the system controller (serial number: (b)(4) and was found to pass all manufacturing and qa specifications before being shipped to the customer.Heartmate iii instructions for use section 2 entitled ¿system operations¿ and heartmate iii patient handbook section 2 entitled ¿how your heart pump works¿ states ¿do not twist, kink, or sharply bend the driveline, system controller power cables, the power module patient cable, or the mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.Damage to the driveline or cables could cause the left ventricular assist device to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.¿ 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

It was reported that on (b)(6).2022, the new controller was noted to have a bend and fatigue at the strain relief at one of the power leads and was exchanged back to the first controller by a healthcare professional.Related mfr: 2916596-2022-11644.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 14836835
• MDR Text Key: 294934832
• Report Number: 2916596-2022-11649
• 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
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7167579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: Black Or African American