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 12/08/2023

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 the coring knife was dull.A scalpel was used for the coring procedure with no repercussion to the patient.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the returned apical coring knife, serial number (b)(6), confirmed the reported event of the coring knife not being sufficiently sharp.The apical coring knife, serial number (b)(6), was returned in a plastic bag.The coring knife was in used condition as residue consistent with blood was present on its internal body.Initial visual inspection of the blade revealed visible irregularities in the blade edge.Microscopic inspection further revealed multiple imperfections of the blade edge.These imperfections consisted of folds/chips to the blade edge which appeared to have the potential to contribute to a cutting issue.A cut test was performed with the returned coring knife and a silicone sheet.The knife was unable to cut through the silicone sheet as expected, consistent with the reported event.It should be noted that a control apical coring knife was able to cut through the same silicone sheet 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 21 aug 2023.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 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.

Event Description

Additional information was received that there was no delay in surgery due to the dull coring knife.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18382744
• MDR Text Key: 331193809
• Report Number: 2916596-2023-08670
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010227
• UDI-Public: 00813024010227
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1050
• 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: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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 Sex: Male
• Patient Weight: 83 KG