MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE APICAL CORING KNIFE; VENTRICULAR (ASSIST) BYPASS

Model Number 1050

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the surgeon was unable to complete the coring of the ventricle with the coring knife.Coring was completed with scissors.The surgeon noted that it was fine at the start, but it didn't cut all the way through.The surgeon stated that there was no scarring or calcium in the way that could have hindered coring.The coring knife was fine for about three quarters of the way then scissors had to be used to finish coring.There were no patient consequences or delay in surgery as a result of the event.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the returned coring knife could not confirm the reported event of cutting difficulty.A specific cause for the reported event could not be conclusively determined.The coring knife, serial number (b)(6), was returned with the protective blade plastic caps on each end.The coring knife handle was not returned.The coring knife was in used condition with blood residue present on the external and internal body, as well as the blade edge.Microscopic inspection of the coring knife found minor imperfections in the blade edge as well as an area of the blade edge with a rolled edge and a hanging burr.The remainder of the blade edge appeared largely unremarkable.A specific cause for the imperfections in the blade edge could not be conclusively determined, and it was unknown if the imperfections were present prior to knife handling or use.A cut test was performed with the returned coring knife and a foam sheet.The coring knife completely cut through the foam sheet without resistance.Review of manufacturing documentation found no deviations from manufacturing or quality specifications.Although the reported event could not be reproduced during the evaluation of the returned coring knife, 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 specification.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: HEARTMATE APICAL CORING KNIFE
• Type of Device: 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: 18861302
• MDR Text Key: 337676007
• Report Number: 2916596-2024-01467
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: 00813024010227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 1050
• Device Lot Number: 10108295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 106 KG