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

Model Number	10005872
Medical Device Problem Codes	Mechanical Problem (1384); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while unpacking the coring tool, the perfusionist recognized a bend in the center pin and the helix of the coring tool.Another coring tool was used.
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 further reported that hospital recognized the damage, and another coring tool was used.There were no patient consequences.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned coring tool and submitted photographs confirmed damage to the guide pin and helix; however, a specific cause for this damage could not be conclusively determined through this evaluation.The coring tool was returned in used condition.Residue consistent with blood was present on the ends of the guide pin and helix.Visual inspection revealed that the guide pin was bent and protruding through the end of the helix coil.The helix coil was also observed to be slightly bent in the same direction as the center pin.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 submitted photographs captured residue consistent with blood on the tool handle and blade body.Additionally, the photos captured the helix coil bent in a different direction than the guide pin.This direction of bending did not appear to be consistent with the returned state of the product, suggesting that additional bending occurred after the submitted photographs were taken.Review of the manufacturing documentation, which includes inspecting the tool for damage, found no deviations from manufacturing or quality assurance specifications.This evaluation could not conclusively determine when or how the guide pin and helix initially became bent.The heartmate 3 lvas instructions for use (ifu), rev.B, is currently available.Section 5 of the ifu, "surgical procedures", 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.G, 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 appropriate abbott medical personnel if there is a change in how the device works, sounds, or feels.The ifu also states to ensure that that the coring tool is not damaged prior to use.The relevant sections of the device history records for heartmate 3 coring tool, lot number 10588934, were reviewed and showed no deviations from manufacturing or quality assurance specification.The coring tool lot passed all inspection steps, including inspection steps in place for identifying a bent pin or helix.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was later reported that according to the customer the bend center pin was observed immediately after unpacking the coring tool.Contamination with blood was a result as the customer tried to use it anyway.As it was not possible to use it with the bend pin, they opened the backup coring tool.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22126227
• Report Number: 2916596-2025-03547
• Device Sequence Number: 20656072
• Product Code: DSQ
• UDI-Device Identifier: 00813024013075
• UDI-Public: (01)00813024013075(10)10588934(17)271106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

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 Model Number: 10005872
• Device Catalogue Number: 10005872
• Device Lot Number: 10588934
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 08/06/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/26/2025; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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