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

Model Number AR-17014

Device Problems Collapse (1099); Infusion or Flow Problem (2964); Material Deformation (2976); Pressure Problem (3012)

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

Event Date 12/03/2020

Event Type  malfunction  

Event Description

During minimally invasive cardiac surgery, the 14-gauge livanova needle was inserted into the ascending aorta.When the cardiac surgeon cross-clamped the aorta and the perfusionist attempted to deliver cardioplegia, the cardioplegia flow would not flow more than 100cc's per minute without reaching a high line pressure alarm.The surgeon removed the cross-clamp from the aorta and assessed that the aorta was fine.The surgeon re-cross-clamped and had the same problem of high line pressures with only 100ccs of flow, however the aorta was responding appropriately and there was no evidence of harm to the heart.Therefore, the surgeon decided to continue the surgical procedure.When taking the needle out of the aorta at the end of the case, it was very apparent upon inspection that the needle was deformed.The needle was never clamped down on by an instrument.It looks like it collapsed while in the aorta.

• Brand Name: CARDIOPLEGIA CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 12245318
• MDR Text Key: 264074206
• Report Number: 12245318
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-17014
• Device Lot Number: 2027900069
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 83