MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS CORING TOOL; SURGICAL CORING TOOL

Model Number	10005872
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximate age of device ¿ 1 day (the day of implant).The patient remains ongoing on lvad support.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that during the left ventricular assist device (lvad) implantation, the surgeon used the coring tool for the ventriculotomy.The left ventricle (lv) tissue thickness was 10 mm.The surgeon used the coring tool correctly but the tool did not move in the lv tissue preparation.The tool was removed from the tissue counterclockwise.The section was correct and the tissue preparation was complete and could be removed with tweezers.No further information was provided.
Additional Manufacturer Narrative
Additional information.Manufacturer's investigation conclusions: although damage to the coring tool was confirmed during the evaluation, a correlation to the reported event could not be conclusively determined.Examination of the returned coring tool confirmed that the guide pin inside the cutting blade was bent, contacting the helix.The inspection found no other areas of damage to indicate how the pin may have been bent.Review of the manufacturing documentation, which includes inspecting the tool for physical damage, found no deviations from manufacturing or quality assurance specifications.The evaluation could not determine when the guide pin in the returned coring tool became bent.Functional testing of the coring tool found the blade to be within manufacturing specification in its returned state.Additional testing using a different but similarly damaged coring tool found that a tool in this state was able to core and capture the tissue from a test section of bovine myocardium, although the resulting hole was angled.The bent guide pin could not be conclusively correlated to report of the tissue core not being captured by the tool.No further information was provided.The patient remains ongoing on the device.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS CORING TOOL
• Common Device Name: SURGICAL CORING TOOL
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8415251
• Report Number: 2916596-2019-01117
• Device Sequence Number: 1516188
• Product Code: DSQ
• UDI-Device Identifier: 00813024013075
• UDI-Public: 00813024013075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 10/06/2021
• Device Model Number: 10005872
• Device Catalogue Number: 10005872
• Device Lot Number: 6677924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q119-MCS-1
• Patient Sequence Number: 1