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	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon stated the apical coring knife was dull.The coring knife was unable core the ventricle and the surgeon used a traditional blade to complete the coring needed for left ventricular assist device (lvad) insertion.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
D4, h4: updated device serial number, udi number, manufacture and expiration dates.G3: pma number added.Manufacturer's investigation conclusion: evaluation of the returned coring knife, serial number (b)(6), could not confirm the reported event of the knife not being sufficiently sharp.A specific cause for the reported event could not be conclusively determined through this evaluation.The coring knife, serial number (b)(6), was returned with both blade caps and handle unattached.The coring knife was in used condition as residue consistent with blood was present on its internal and external body as well as the blade edge.Areas of the blade were also covered in a small amount of rust.Initial visual inspection of the blade did not reveal any obvious damage or irregularities.Microscopic inspection of the coring knife was performed, and areas of rust were observed on the knife and blade edge, consistent with fluid contact during the patient's implant surgery.Further microscopic inspection of the blade edge revealed no major imperfections.A cut test was performed with the returned coring knife and a polyurethane test pad.The knife was able to cut through this material without issue and functioned as intended.Review of manufacturing documentation found no deviations from manufacturing or quality specifications.In addition, a capa 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.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.

• 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: 20995697
• Report Number: 2916596-2024-52637
• Device Sequence Number: 4567138
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)251109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/27/2025

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: 11/09/2025
• Device Model Number: 1050
• Device Catalogue Number: 1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic