MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CANNULA ACCESSORIES

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Case (b)(4).The cannula (csk-6130) was not returned for evaluation.A device history review for the csk-6130, lot number 113677, was conducted and there is nothing that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported by the sales rep that on (b)(6) 2022 a female patient underwent a staged hybrid ablation and left atrial appendage exclusion procedure.The subtle cannula was retracted and reinserted by the physician multiple times in an attempt to improve visibility.The final time the cannula was retracted, significant bleeding was noted and the patient became hypotensive.Procedure was converted via a sternotomy and the patient was put on-pump.Inspection of the injury revealed a perforation of an unknown anomalous vein, outside of atrium and laying adjacent to ivc.The patient required transfusion and the injury was repaired with a prolene suture.Post-operatively, the physician indicated the patient was stable.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The cannula (csk-6130) was not returned for evaluation.A device history review for the csk-6130, lot number 113677, was conducted and there is nothing that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported by the sales rep that on (b)(6) 2022 a female patient underwent a staged hybrid ablation and left atrial appendage exclusion procedure.The subtle cannula was retracted and reinserted by the physician multiple times in an attempt to improve visibility.The final time the cannula was retracted, significant bleeding was noted and the patient became hypotensive.Procedure was converted via a sternotomy and the patient was put on-pump.Inspection of the injury revealed a perforation of an unknown anomalous vein, outside of atrium and laying adjacent to ivc.The patient required transfusion and the injury was repaired with a prolene suture.Post-operatively, the physician indicated the patient was stable.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: CANNULA ACCESSORIES
• Type of Device: CANNULA ACCESSORIES
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 13522871
• MDR Text Key: 285532911
• Report Number: 3011706110-2022-00003
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CANNULA ACCESSORIES
• Device Catalogue Number: CSK-6130-3
• Device Lot Number: 113677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2021
• 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
• Treatment: AOD1 CLIP
• Patient Outcome(s): Life Threatening
• Patient Sex: Female