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

Model Number	106533
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 tunneling lance (short version) was no longer able to be connected to the handle on one side.The backup tunneler was used.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned tunneling lance confirmed the reported connection issue, which was found to be due to deformation of the tunneling lance end; however, a specific cause for the deformation could not be conclusively determined.A used, 16¿ tunneling lance was returned for evaluation.One of the ends that interacts with the tunneler handle was deformed while the other appeared normal.The returned tunneler was measured to be within specification at the thickest part of the tunneler threads and at the hexagonal heights of its ends.The deformation of the tunneler end, where it interacts with the handle, was measured and found that it could have caused a connection issue.Connection was attempted between the returned tunneler and a test handle, as the handle was not returned.The normal tunneler end was able to be fit into the handle without issue, while the deformed tunneler end was not able to be fully fit into the test handle.The cause of the connection issue appeared to be the deformation of the tunneler end; however, a specific cause for the deformation could not be conclusively determined.The relevant sections of the available device history records were reviewed, which showed no deviations from manufacturing or quality assurance specifications.It was unable to be conclusively determined which abbott batch # the returned device was from using only the supplier batch #880931, so the relevant sections of the device history records for all possible batch #¿s (7082763, 7082764, and 7082812) were reviewed which showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 5 ¿surgical procedures¿ (under ¿creating the exit site¿) provides instructions for use of the tunneling lance and handle.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 iii 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 current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20923433
• Report Number: 2916596-2024-52575
• Device Sequence Number: 8286070
• Product Code: DSQ
• UDI-Device Identifier: 05415067038432
• UDI-Public: (01)05415067038432
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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
• Device Catalogue Number: 106533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown