MAUDE Adverse Event Report: ABBOTT MEDICAL, COSTA RICA LTDA AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 8.5F; INTRODUCER, CATHETER

Model Number	G408324
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an af procedure using ensite x in voxel mode, there was an air leak through the sheath.The sheath was exchanged, and the procedure was finished successfully without any adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h11.One 8.5f agilis steerable introducer sheath was received for evaluation.The dilator was also received.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22175819
• Report Number: 3008452825-2025-00267
• Device Sequence Number: 7957779
• Product Code: DYB
• UDI-Device Identifier: 05414734206150
• UDI-Public: (01)05414734206150(10)10525383(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G408324
• Device Catalogue Number: G408324
• Device Lot Number: 10525383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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
• Patient Sex: Male