MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, 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 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the coring knife was dull and not cutting into the myocardium.The difficulty was encountered at the very start of the coring procedure.The surgeon used a scalpel and scissors to core the apex.It was noted that the patient's myocardium was scarred and fibrotic which could have contributed.There was no patient consequence or delay in surgery as a result of the event.

Manufacturer Narrative

Section d4: catalog number and udi corrected.Section d4: expiration date: additional information.Section d6a: implant date was inadvertently added in initial report and is not applicable for this product.Section h4: device manufacture date: additional information.Manufacturer's investigation conclusion: the reported event was confirmed during evaluation of the returned coring knife, serial number (b)(6).The coring knife, serial number (b)(6), and the coring knife handle were returned is used condition, loose in a bag.The protective caps were not returned.Residue consistent with blood was present on the internal and external body of the knife, the blade edge, and the coring knife handle.Initial visual inspection of the blade did not reveal any obvious damage or irregularities.The coring knife was then visually inspected using a microscope.A small amount of debris was observed along the blade edge that appeared to be consistent with blood that had adhered to the blade edge during implant surgery.Additional microscopic inspection revealed that the blade edge had multiple imperfections consisting of burrs which appeared to have the potential to contribute to a cutting issue.A cut test was performed with the returned coring knife and a polyurethane sheet.The knife was unable to cut through the polyurethane sheet as expected, consistent with the reported event.It should be noted that a control coring knife used for comparison was able to cut through the same polyurethane sheet without issue after approximately a quarter turn.An internal investigation by abbott has determined that issues 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 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 by manufacturing analysis task.The heartmate (hm) 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: THORATEC® HEARTMATE II®, 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18857332
• MDR Text Key: 337673918
• Report Number: 2916596-2024-01174
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 1050
• Device Catalogue Number: 1050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White