MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number	CSK-6130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011706110-2022-00038
• Device Sequence Number: 6372426
• Product Code: OCL
• UDI-Device Identifier: 50840143900219
• UDI-Public: 50840143900219
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K193162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CDK-1413, ATRICLIP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male