MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 TUNNELING LANCE AND HANDLE; VENTRICULAR (ASSIST) BYPASS

Model Number	106533
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the 16 inch tunneling set was not engaging to the handle correctly and that there was too much to give when it was pulled back to check the connection.The handle on the 24" tunneler was used to see if the same problem occurred and it was determined that it was solely 16 inch tunneling set.
Additional Manufacturer Narrative
Manufacture¿s investigation conclusion: the reported event could not be confirmed as no product was returned for investigation.According to the account, the issue was due to wear and tear.It was reported that the 16 inch tunneling lance could not be engaged to the tunneling handle properly as "there was too much give" when it was pulled to inspect the connection.The handle was then used with a 24 inch tunneling lance and it was determined that the problem only occurred with the 16 inch tunneling lance as the result of wear and tear to the lance.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The 16" tunneling lance set was not returned - no product is available for investigation.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) provides instructions for use of the tunneling lance and handle in section 5 ¿surgical procedures¿ (under ¿creating the exit site¿).This section cautions the user that "the heartmate 3 tunneling lance and handle are provided non-sterile.Ensure that the lance and handle have been cleaned, inspected, and sterilized in accordance with the provided instructions and hospital policy." the heartmate 3 lvas surgical tools cleaning and sterilization ifu provides information regarding the cleaning, drying, packaging, sterilization, storage, and maintenance of heartmate 3 surgical tools, including the tunneling lance and handle, and cautions that the provided instructions must be followed to ensure proper sterility levels and device functionality.In addition, this document states that end of life is normally determined by wear and damage due to use.The user must ensure that the tunneling lance can be inserted and removed from the handle.This ifu cautions the user that if damage or wear is noted that may compromise the function of the instrument, the equipment should not be used, and the appropriate responsible person should be notified.This document further cautions that the instrument may never be heated to above 140°c.The lot number of the tunneling lance set was not provided and could not be determined through this evaluation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 TUNNELING LANCE AND HANDLE
• Common Device Name: 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: 16297699
• Report Number: 2916596-2023-00517
• Device Sequence Number: 18029651
• Product Code: DSQ
• UDI-Device Identifier: 00813024013211
• UDI-Public: 813024013211
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 106533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown