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

Model Number	1050
Medical Device Problem Codes	Dull, Blunt (2407); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a: patient gender was requested but not provided.Manufacturer's investigation conclusion: evaluation of the returned coring knife, serial number (b)(6), did not confirm an issue related to knife dullness.The coring knife, serial number (b)(6), was returned in a plastic jar in unused condition.The handle was not returned.The protective caps were present on the knife and were secured with string.Visual and microscopic inspection did not reveal any evidence of damage or defect.A cut test was performed with the returned coring knife and a polyurethane sheet.The knife was able to cut through this material without issue, comparable to a control knife.Review of the coring knife manufacturing documentation found no deviations from manufacturing or quality specifications.These inspections include a cut test and visual inspection of the knife edge under magnification.Coring knife, serial number (b)(6), passed all testing and inspection.Incidental findings: visual inspection revealed an unknown residue adhered to the knife body.A manufacturing analysis task was completed to further investigate this finding.Per the investigation, the unknown residue presence was not determined to be manufacturing related.A specific cause for the unknown residue presence could not be conclusively determined through this evaluation.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 left ventricular assist system (lvas) ifu is currently available.Chapter 1, "introduction", lists the apical coring knife as an optional component for device implantation.Chapter 5, ¿surgical procedures¿, provides information on preparing and handling the coring knife.This chapter 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 surgeon decided to use a stand-alone coring knife due to recent concerns about the dullness of the coring knife in the implant kit.The stand-alone coring knife was used with no issues.The coring knife in the implant kit was being sent back unused.

• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24109372
• Report Number: 2916596-2026-00179
• Device Sequence Number: 5789802
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)280310
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

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: 1050
• Device Catalogue Number: 1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• 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: 01/07/2026
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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: 4 YR
• Patient Sex: Unknown
• Patient Weight: 26 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American