MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CSK-6130

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4) the cannula device was returned for evaluation and was visually and functionally tested.The complaint could not be confirmed.The cannula device passed evaluation.

Event Description

It was reported on (b)(6) 2022, a 78-year-old male patient underwent a staged hybrid therapy and concomitant left atrial appendage exclusion procedure.During the minimally invasive procedure, physician observed bleeding, that in his medical opinion, necessitated conversion of access to median sternotomy.Conversion to sternotomy was performed in order to preclude potentially life-threatening injury.However, upon visualization/examination of heart and surrounding structures through median sternotomy access, no source for observed bleeding was identified, thus no further interventions were performed.The ablation procedure was completed as planned.This was a procedural complication with no reported device malfunctions.

• 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: 15668915
• MDR Text Key: 302399824
• Report Number: 3011706110-2022-00038
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 50840143900219
• UDI-Public: 50840143900219
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSK-6130
• Device Catalogue Number: CSK-6130
• Device Lot Number: 114300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CDK-1413, ATRICLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male