MAUDE Adverse Event Report: LIVANOVA USA AORTIC ROOT CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number AR-11112

Device Problem Defective Component (2292)

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

Event Date 12/04/2023

Event Type  Injury  

Event Description

Livanova usa received a report that surgeon was using the ar-11112 and was got stubbed using the steel introducer needle.There is no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova usa manufactures the aortic root cannula.The incident occurred in usa.Complained cannula has been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: the complained unit was returned to livanova for investigation, along with 9 other unused units from the same lot that were refused by customer.Visual inspection concluded that the device was manufactured properly per manufacturing procedures.When the steel introducer needle was being pulled out of the cannula, the luer was slightly more difficult to twist, however that may have been due to the fluid that dried on the device causing it to stick.Once the luer was untwisted, there were no issues removing the needle and it functioned properly.Dimensional analysis was performed on critical dimensions that could contribute to the needle being more difficult than usual to remove, on the tubing and on the needle.All dimensions were found to be within specifications.Visual inspection was performed also on the 9 unused units and these were manufactured properly per manufacturing procedures.All luers were untwisted with minimal effort and there were no issues removing the needle.The device history record (dhr) review highlighted that the lot whose claimed product belongs to was released as conform according to specifications.No similar complaints have been recorded on this product lot out of 300 manufactured units nor part number in the last 5 years.Therefore, the event is isolated.Upon reviewing product change history, no changes that would contribute to the reported complaint were identified.Based on all the above, it cannot be ruled out that the reported event could have been due to the needle luer that may have been assembled too tightly to the female connector of cannula tubing during manufacturing, making needle withdrawal harder for the surgeon.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.

• Brand Name: AORTIC ROOT CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18433430
• MDR Text Key: 331865130
• Report Number: 1718850-2024-00021
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103049
• UDI-Public: (01)00803622103049(240)AR-11112(17)260803(10)2321600074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-11112
• Device Lot Number: 2321600074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 03/30/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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