MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE® XVE AND HEARTMATE II®, 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	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the evaluation of the returned coring knife revealed the cutting blade of the coring knife was dull.
Additional Manufacturer Narrative
No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Section d1: corrected.Section d4: corrected.Manufacturer's investigation conclusion: evaluation of the returned coring knife, serial number (b)(6), confirmed the reported event of the knife not being sufficiently sharp.The coring knife was returned with the protective caps secured over both ends.The coring knife was in like-new condition with no evidence of blood on its body or blade edge.Initial visual inspection of the blade revealed no obvious areas of damage or irregularities along the blade edge.Microscopic inspection revealed a small burr and slightly uneven edges along the blade edge.A cut test was performed with the returned coring knife and a foam sheet.The knife was unable to cut through the foam sheet as expected.A quarter turn of the knife created excessive friction, causing torsion of the sheet.By comparison, a control knife was able to cut through the sheet in a quarter turn 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 device is included in the apical coring knife unable to cut advisory issued by abbott on 21aug2023 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE® XVE AND HEARTMATE II®, 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19354157
• Report Number: 2916596-2024-03080
• Device Sequence Number: 7703104
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: (01)00813024010227(17)260621
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 06/21/2026
• Device Model Number: 1050
• Device Catalogue Number: 1050
• Device Lot Number: 8920053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 67 KG