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

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa was informed that, during the implantation of the needle of the cardioplegia cannula, the teflon of the needle is retracted in two attempts.After the second attempt, the surgeon decides to change the needle to another medical device.The procedure was completed with no issue.
Additional Manufacturer Narrative
Patient information were not provided.Livanova usa manufactures the aortic root cannula.The incident occurred in colombia.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The unit was disposed by the customer and no additional detail was provided despite attempts.The dhr review confirmed the device was released conforming to product specifications.No similar events were recorded on the same lot involved by reviewing the complaints database.Therefore, a systematic deficiency of the product quality can be excluded.Based on the available information, it cannot be excluded that an isolated manufacturing deviation occurred during the assembly phase due to a poor connection but enhanced by the customer's conditions of use.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: AORTIC ROOT CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; 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: 16563370
• Report Number: 1718850-2023-00024
• Device Sequence Number: 17513038
• Product Code: DWF
• UDI-Device Identifier: 00803622103018
• UDI-Public: (01)00803622103018(17)250831(10)2224200037(11)220906(240)AR-11014
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11014
• Device Lot Number: 2224200037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown