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

Model Number 1050

Device Problem Dull, Blunt (2407)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that the coring knife was noted to be dull by the surgeon.An 11 blade was also used, and there was no delay in the procedure.There were no patient consequences.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the returned coring knife, serial number (b)(6) , confirmed damage that could have potentially contributed to the report of the knife being dull.The coring knife, serial number (b)(6) , was returned in a plastic container with the protective cap over the blade end.The coring knife was in used condition with blood and rust present on its external body as well as the internal and external surfaces of the blade edge.Initial visual inspection of the blade revealed areas of damage and irregularities along the cutting edge.Microscopic inspection of the coring knife was performed and revealed that the blade edge had multiple imperfections, including chips and areas that were uneven when observed from a profile view.These imperfections appeared to have the potential to contribute to a cutting issue.A cut test was performed with the returned coring knife and a silicone mat.The knife was unable to cut through this material as expected.It should be noted that a control coring knife, used for comparison, was able to cut through the same mat 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 and a corrective and preventive action (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.However, review of the batch history did confirm that the coring knife was part of the lots bracketed.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
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• 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: 18178800
• MDR Text Key: 328637214
• Report Number: 2916596-2023-07844
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: 00813024010227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: 8920053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q323-HF-3
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White