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	Mechanical Problem (1384); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the edge of the coring knife appeared almost hammered rather than flush.The coring knife cored without issue.There was no functional difference.
Additional Manufacturer Narrative
Section a: no patient was involved.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
B5 narrative 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 during apical coring, the surgeon could not obtain a clear core with the coring knife and could only partially core.The coring was completed with an 11-blade knife.The ventricle was not noted to be thick and there was no thrombus present.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of the edge of the coring knife appearing almost hammered rather than flush can be confirmed based on the evaluation of the returned coring knife.The coring knife, serial number (b)(6), was returned in a plastic sample jar.The knife edge slightly dug into the side of the 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.Small rust spots were observed on some areas of the knife.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 several small spots of rollover, likely from hitting sides of the jar, and a small void was observed in an area of rust.A cut test was performed using a sheet of polyurethane foam.The knife cut completely through the sheet in less than one-quarter rotation while applying light pressure.The test was repeated two additional times with identical results.A test coring knife was also used to cut the polyurethane sheet and felt comparable to the returned knife.The relevant sections of the device history records were reviewed and showed no deviations from mfg 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.

• 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: 21082218
• Report Number: 2916596-2024-52830
• Device Sequence Number: 15560391
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/28/2025

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
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 03/27/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/09/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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 Sex: Unknown