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

Model Number 1050

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that per surgeon request, it was determined prior to the procedure to use the stand-alone coring knife given the implant kit was included on the coring knife device correction list.Stand-alone coring knife was used during procedure and surgeon reported stand-alone coring knife did not completely cut through left ventricle and bovie (electrocauterization) was used to cut the remaining tissue.Surgeon reported it was unsure if coring knife did not cut through left ventricle due to surgical error or due to dull knife.The patient was status post heartmate 3 (hm3) left ventricular assist device (lvad) and in the progressive care unit undergoing lvad education.

• Brand Name: HEARTMATE APICAL CORING KNIFE
• Type of Device: 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: 18521435
• MDR Text Key: 333001336
• Report Number: 2916596-2024-00097
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: 813024010227
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 95 KG