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

Model Number	10005872
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that during a heartmate 3 implant, a coring tool used had no tissue core come out with it during the coring process.After examination of the tool, the metal spike appeared to be outside of the spiral which is abnormal.A visual inspection was performed, and no core was found in the patient's heart or chest.An echocardiogram, endoscopic procedure and computerized tomography angiography were also performed to check for the core; no core was found.The patient's ventricle was noted to be slightly calcified.The patient was progressing well after their implant.The site sent the tool back for analysis.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: although damage to the coring tool guidepin was confirmed during the evaluation, a direct correlation to the report of the tissue core not being captured could not be determined.Examination of the returned coring tool found no damage or defect along the blade edge.The alignment pin inside of the helix was bent and the tip of the pin was contacting the inside diameter of the blade.No tissue or tissue remnants were found on the helix or inside the tool.After cleaning, the tool was functionally tested using a porcine heart.The coring tool successfully cored the heart on all five attempts, capturing the core each time, as designed.The bent pin caused the tool to rotate off-center during each use, but did not prevent coring or capturing of the porcine heart tissue.Review of the manufacturing documentation, which includes inspecting the guidepin for bending, found no deviations from manufacturing or quality assurance specifications.The evaluation could not determine the cause of the observed guidepin damage or why the tissue core was not captured during the implant procedure.The patient remains ongoing on vad support and no further issues have been reported.The device history records were reviewed and showed no deviations from manufacturing or qa specifications.The heartmate 3 (hm3) coring tool instructions for use (ifu) provides information on using the enhanced coring tool.The ifu warns the user to ensure the coring tool is not damaged prior to use.The device should not be used if it appears to be damaged in any way.The user should not try to repair the coring tool system components.Notify thoratec personnel if there is a change in how the device works, sounds, or feels.The packaging, surgical enhancement tools, coring tool assembly includes inspection criteria for the coring tool.Sections 7.4.13 and 8.3.3 instruct the operator to inspect the coring tool for damage and specify checking for a bending of the pin.The packaging, surgical enhancement tools, coring tool assembly instructs the operator to inspect the coring tool for discoloration, bent pin, physical damage, crack, and foreign matters under step 7.4.13.Any nonconforming parts should be scrapped without an ncmr using mtf.The heartmate 3 ifu provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 CORING TOOL
• Common Device Name: VENTRICULAR (ASSISST) 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: 12807609
• Report Number: 2916596-2021-06207
• Device Sequence Number: 5575966
• Product Code: DSQ
• UDI-Device Identifier: 00813024013075
• UDI-Public: 00813024013075
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 10005872
• Device Catalogue Number: 10005872
• Device Lot Number: 7650475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 01/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 119 KG