MAUDE Adverse Event Report: LIVANOVA USA AOR ROOT CAN W/OUT VENT LN 12G; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number AR-11012

Device Problem Disconnection (1171)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the aoritc root cannula.The incident occurred in usa.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa receieved a report that during a procedure, the distal p plastic cap of the metal needle of the aorting cannula came off when inserted.This caused patient to have blood loss from aorta.There is no report of any patient injury.

• Brand Name: AOR ROOT CAN W/OUT VENT LN 12G
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 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: 19212229
• MDR Text Key: 341374900
• Report Number: 1718850-2024-00028
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103001
• UDI-Public: (01)00803622103001(240)AR-11012(17)251031(10)2230500006
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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: AR-11012
• Device Lot Number: 2230500006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2022
• 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