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 08/28/2023

Event Type  malfunction  

Event Description

It was reported that during the implant procedure it was not possible to core the left ventricle.The surgeon had to use scissors and normal blades to remove the tissue from the ventricle.The patient's ventricular wall was thick which contributed to the cutting difficulty.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that there were no patient consequences, although surgery time was prolonged by 15 to 20 minutes due to apical knife failure.

Manufacturer Narrative

Reporter email: (b)(6) manufacturer's investigation conclusion: evaluation of the returned coring knife could not confirm the reported event of cutting difficulty.A specific cause for the reported event could not be conclusively determined through this evaluation.The coring knife, serial number (b)(6), was returned in its respective plastic tray with the protective blade cap present, but not covering the blade.The dull end cap was present and attached to the dull end of the knife.The coring knife handle, skin punch, tunneling adapter and thread protectors were returned loose in the tray.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 of the coring knife was performed and areas of rust were observed on the knife and blade edge, consistent with fluid contact during the patient's implant surgery.Further microscopic inspection of the blade edge revealed no major imperfections.A cut test was performed with the returned coring knife and a silicone material.The knife was able to cut through this material without issue and functioned as intended.Review of manufacturing documentation found no deviations from manufacturing or quality specifications.In addition, a capa was opened to further investigate issues related to the coring knife not being able to cut.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), 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: 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: 17663673
• MDR Text Key: 322444783
• Report Number: 2916596-2023-06474
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: 00813024010227
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050
• Device Lot Number: 8867224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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 Sex: Male
• Patient Weight: 90 KG