MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CANNULA ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Great Vessel Perforation (2152)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Case (b)(4) upon receipt, the cannula, lot number 107244, was visually and functionally inspected pursuant to specific atricure investigation procedures.The complaint was not confirmed, cannula did not have any sharp edges.

Event Description

It was reported that on (b)(6) 2021 a (b)(6) year-old-female with a history of atrial fibrillation and obesity underwent an off-pump staged convergent left pulmonary vein isolation and left atrial management (laam) procedure.During initial cannula insertion, the subtle cannula contacted the inferior vena cava (ivc) and bleeding occurred that required the procedure to be converted to a sternotomy.The ivc was sutured.A laa040 atriclip was placed on the laa and the procedure was completed without further complications.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: 12068643
• MDR Text Key: 264771890
• Report Number: 3011706110-2021-00034
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: CANNULA ACCESSORIES
• Device Catalogue Number: CSK-6130
• Device Lot Number: 107244
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2020
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR