MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 CORING TOOL; VENTRICULAR (ASSIST) 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	07/21/2022
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 there was a coring tool pin malfunction.The pin on the coring tool was crooked when pulled out of the left ventricle.It was protruding through the helix instead of central to the helix after deployment of the blade.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of a bent guide pin was confirmed through evaluation of the returned coring tool.The coring tool was returned in used condition.The blade was identified with number (b)(6).Visual inspection found that the guide pin inside the blade was bent and protruding through the helix coil.Under magnification, the edge of the cutting blade appeared unremarkable.The locking tabs on the rear of the tool appeared to function as intended.The patient remains ongoing with no further issues reported at this time.The heartmate 3 left ventricular assist system (lvas) instructions for use (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 device history records for lot number 8349893 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), rev.C, 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, rev.F, 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.
Event or Problem Description
Additional information: there was no adverse effect to the patient.

• 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: 15196247
• Report Number: 2916596-2022-12819
• Device Sequence Number: 17745892
• Product Code: DSQ
• UDI-Device Identifier: 00813024013075
• UDI-Public: 00813024013075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 03/02/2025
• Device Model Number: 10005872
• Device Catalogue Number: 10005872
• Device Lot Number: 8349893
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 08/21/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: Black Or African American