MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 CORING TOOL; VENTRICULAR (ASSIST) BYPASS

Model Number	10005872
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
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 surgeon was utilizing the coring tool and it required more than 3 rotations once the helix was in the ventricle.Post-operative the patient was doing well.The malfunction did not result in prolonged surgery time and the product will not be returned for evaluation.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the reported difficulty coring the apex of the patient¿s heart with the heartmate coring tool could not be conclusively determined through this evaluation.The coring tool was not returned, and no photos of the event were submitted for evaluation.The patient remains ongoing with no further issues reported at this time.The coring tool was not returned for evaluation.The device history records for lot number 8379685 were reviewed and showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 left ventricular assist system (hm3 lvas) instructions for use (ifu) is currently available.Section 5 of the ifu provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.The heartmate 3 coring tool ifu contains information needed to properly and safely use the heartmate 3 coring tool to core the left ventricle and remove cored tissue.The ifu instructs the user to notify thoratec personnel if there is a change in how the device works, sounds, or feels.The ifu also states that ¿if resistance is felt while removing the coring tool from the ventricle then the tissue may not be fully cored¿ and provides instructions on how to cut the remaining tissue.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 CORING TOOL
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15552113
• Report Number: 2916596-2022-14395
• Device Sequence Number: 5959593
• Product Code: DSQ
• UDI-Device Identifier: 00813024013075
• UDI-Public: 00813024013075
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: 03/17/2025
• Device Model Number: 10005872
• Device Catalogue Number: 10005872
• Device Lot Number: 8379685
• Was Device Available for Evaluation?: No
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White