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	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device 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 completed.
Event or Problem Description
It was reported that surgeon went to core left ventricle, and the coring knife did not make a complete cut despite counter tension with foley balloon.The surgeon questioned whether they were handed the dull side.It noted by an oversevere of the coring that it was the sharp side towards apex of left ventricle.The surgeon completed the core with #11 blade.The surgeon wanted the coring knife evaluated.The coring knife was in the implant kit.There was no harm caused to the patient, nor delay in surgery.Per the surgeon, it never felt normal.The knife never felt like it was cutting.The ventricle was not thick, no muscle involvement which was confirmed on echocardiogram by the surgeon.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the evaluation of the returned coring knife did not reveal an issue that would have contributed to the reported event.The coring knife was returned without the handle or end caps.The knife showed witness marks from the manufacturing process around the sharpened end but no evidence of damage was noted.Visual inspection of the knife under a microscope did not reveal any areas of damage or defect to the blade edge.The coring knife passed cut testing and felt comparable to the same cut test performed with a test 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 s/n (b)(6) passed all testing and inspection.The cause of the reported event could not be determined.The relevant sections of the device history records were reviewed and showed no deviations from mfg or qa specifications.The receiving inspection information (batch # 10276665) 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.

• 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: 20048470
• Report Number: 2916596-2024-05386
• Device Sequence Number: 15437348
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(11)240501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American