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	08/07/2024
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 was dull out of box and was unable to penetrate the ventricle.The surgeon stated they applied pressure and tried very hard but the knife did not cut.Ventriculotomy was created with a scalpel and scissors.No adverse effects were noted.
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
Additional information was received that there was no more than a 30 second delay due to the dull coring knife.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned coring knife, serial number (b)(6), confirmed damage that could have potentially contributed to the report of the knife being dull.A specific cause for the reported event could not be conclusively determined through this evaluation.The coring knife, serial number (b)(6), was returned in a plastic container.The coring knife was in used condition with rust present on its external body as well as the internal and external surfaces of the blade edge.Initial visual inspection of the blade revealed areas of damage and irregularities along the cutting edge.Microscopic inspection of the coring knife was performed and revealed that the blade edge had minor imperfections, including chips and areas that were uneven when observed from a profile view.These imperfections appeared to have the potential to contribute to a cutting issue.A cut test was performed with the returned coring knife and a silicone mat.The knife was unable to cut through this material as expected.It should be noted that a control coring knife, used for comparison, was able to cut through the same mat without issue.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), rev.C, 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: 20085547
• Report Number: 2916596-2024-05443
• Device Sequence Number: 20732765
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/22/2024

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: Health Professional
• Device Expiration Date: 12/16/2025
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 11/20/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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
• Patient Weight: 108 KG