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	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the coring knife from the implant kit was blunt and the surgeon was unable to punch the heart muscle with it.The replacement stand-alone coring knife was opened.However, it was also found to be blunt.The surgeon then used scissors and a scalpel.
Additional Manufacturer Narrative
B5: additional information.D4 : serial number added.D10: product return date added.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
Additional information was received that the surgeon mentioned that the coring knife felt blunt at the very beginning.There was no patient consequence or delay in surgery as a result of the event.
Additional Manufacturer Narrative
Section d4 - serial number - corrected.Section d4, primary udi number: corrected.Manufacturer's investigation conclusion: evaluation of the returned coring knife, serial number: (b)(6), did not confirm a device-related issue that would have contributed to the reported event.Microscopic inspection of the coring knife was performed, and some areas of rust were observed along the blade edge, consistent with fluid contact during the patient's implant surgery.Additional microscopic inspection revealed that the blade edge had multiple imperfections, consisting of small voids, but the majority of blade appeared unremarkable.A cut test was performed with the returned coring knife and a foam mat.The coring knife felt comparable to the same cut test performed with a test coring knife.The observed damage on the returned knife did result in added tactile feedback during the cut but no additional force or rotation of the knife was required to complete the cut.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) 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: 19602609
• Report Number: 2916596-2024-03759
• Device Sequence Number: 11598348
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

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: Lay User/Patient
• Device Expiration Date: 08/03/2026
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 09/09/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/07/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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