MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE APICAL CORING KNIFE; VENTRICULAR (ASSIST) BYPASS

Model Number	1050
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 implant procedure, the coring knife was used in the normal fashion to attempt at coring the left ventricular apex of the heart.The surgeon stated that it would not work to cut into the tissue stating that it was too dull of a blade.The customer opened an additional heartmate 3 implant kit in order to get an accessory tray out to provide the surgeon with another coring knife.The second coring knife worked in the usual fashion to cut the left ventricular tissue.
Event or Problem Description
The retrieval of an additional coring knife resulted in a delay of approximately 3-5 minutes.There were no patient consequences.
Additional Manufacturer Narrative
Manufacturer's investigation conclusions: evaluation of the returned coring knife, serial number (b)(6), confirmed the reported event of the knife not being sufficiently sharp.The coring knife, serial number (b)(6), and the coring knife handle were returned.The coring knife was in used condition as residue consistent with blood was present on its internal and external body, as well as the blade edge.Microscopic inspection revealed that the blade edge had multiple imperfections.These imperfections consisted of folds/chips to the blade edge which appeared to have the potential to contribute to a cutting issue.A cut test was performed with the returned coring knife and a silicone material.The knife was unable to cut through the silicone material as expected, consistent with the reported event.It should be noted that a control coring knife was able to cut through the same silicone material without issue.An internal investigation by abbott has determined that the issue with the coring knife cutting edge was the result of a manufacturing issue traced to the coring knife supplier.Review of manufacturing documentation confirmed that the coring knife was part of the affected batches identified during this internal investigation.A corrective action was opened with the coring knife supplier to prevent recurrence of this issue.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.However, review of the batch history did confirm that the coring knife was part of the lots bracketed by a manufacturing analysis task.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1, "introduction", lists the apical coring knife as an optional component for device implantation.Section 5, ¿surgical procedures¿, provides information on preparing and handling the coring knife.This section also states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.The device is included in the apical coring knife unable to cut advisory issued by abbott on 21 aug 2023.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE APICAL CORING KNIFE
• 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: 17011765
• Report Number: 2916596-2023-02849
• Device Sequence Number: 20551037
• Product Code: DSQ
• UDI-Device Identifier: 00813024013075
• UDI-Public: 813024013075
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 02/07/2026
• Device Model Number: 1050
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q323-HF-3
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 113 KG