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

Model Number	106533US
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the short tunneling lance did not properly engage in the handle of the tunneling tool.The longer version ended up working but it was said they wanted to return the handle and shorter lance for replacement/repair.The longer lance was not preferred by surgeon.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported engagement issue with the tunneling lance could not be confirmed as no product was returned.A specific cause could not be determined through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no further information was provided.The tool was not returned for evaluation.The lot number was not provided.This product is not serialized.The lot number is not printed on the product and is only available on the box/at the time the product is opened.This is not an out of box failure and the failure mode was not noticed at initial use.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu is currently available.The 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.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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23780467
• Report Number: 2916596-2025-07909
• Device Sequence Number: 10105613
• Product Code: DSQ
• UDI-Device Identifier: 00813024013211
• UDI-Public: (01)00813024013211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/18/2026

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: Health Professional
• Device Model Number: 106533US
• Device Catalogue Number: 106533US
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White