MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE; Ventricular (assist) bypass

Model Number	1050
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of the abnormalities on the surface of the edge of the coring knife were confirmed based on the evaluation of the returned coring knife.The coring knife, serial number (b)(6), was returned in a plastic sample jar.Longitudinal witness/finishing marks were visible along the entire angled area of the knife¿s blade end.These marks are consistent with the rework process.Visual inspection of the knife under a microscope did not reveal any major areas of damage or defect to the blade edge; however, there were spots of minor imperfections.Incidental findings: the knife was able to fully cut through the polyurethane test pad; however, there was some resistance compared to the control knife.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or qa specifications.The receiving inspection information indicated that coring knife s/n (b)(6) was part of a batch of reworked knives.The knife passed all functional tests and inspections.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists the apical coring knife as an optional component for device implantation in the introduction section.The surgical procedures section provides information on preparing and handling the coring knife.This section also states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the doctor had noticed some abnormalities in the surface area of the distal end of the coring tool.The tool was subsequently used however, there were no issues with it as well.The physician subsequently kept the tool for an analysis in-house at the hospital.

• Brand Name: THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE
• 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: 22115825
• Report Number: 2916596-2025-03662
• Device Sequence Number: 12528381
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)260708
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: Health Professional
• Device Expiration Date: 07/08/2026
• Device Model Number: 1050
• Device Catalogue Number: 1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• 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: 05/29/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White