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	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3: patient gender not provided.Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the coring tool seemed dull and was unable to cut through the myocardium as easily as it should have and usually does.
Additional Manufacturer Narrative
D4 - udi - correction.Manufacturer's investigation conclusion: the report that the coring knife lacked expected sharpness was unable to be confirmed as it was not returned for evaluation.Of note, review of the coring knife's manufacturing history confirmed that the knife was not part of the batches bracketed as part of abbott's field action.A specific cause for the reported event could not be conclusively determined through this evaluation.During coring of the left ventricle, the surgeon noted that the coring knife seemed dull.It was reported that the coring knife was not able to cut through the myocardium as easily as it should have and usually does.There were no adverse patient consequences.The coring knife, serial number (b)(6), was not returned for evaluation as it was reportedly disposed of.Review of manufacturing documentation found no deviations from manufacturing or quality specifications.In addition, a correction action and preventative action (capa) investigation was opened to further investigate issues related to the coring knife not being able to cut.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.Of note, review of the coring knife's manufacturing history confirmed that the knife was not part of the batches bracketed as part of abbott's field action.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction", lists the apical coring knife as an optional component for device implantation.Section 5, ¿surgical procedures¿, 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.

• 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: 21762670
• Report Number: 2916596-2025-01785
• Device Sequence Number: 8490470
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)271018
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Model Number: 1050
• Device Catalogue Number: 1050
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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: 47 YR
• Patient Sex: Unknown
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American