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

Model Number AR-XXXXX

Device Problem Disconnection (1171)

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

Event Date 02/14/2023

Event Type  malfunction  

Event 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.

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.

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 Description

See intial report.

• Brand Name: AORTIC ROOT CANNULA
• Type of Device: 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
• MDR Text Key: 311686118
• Report Number: 1718850-2023-00024
• Device Sequence Number: 1
• 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
• Reporter Country Code: CO
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2022
• 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