MAUDE Adverse Event Report: ABBOTT MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 13F; INTRODUCER, CATHETER

Model Number	SI-1371-L
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During af ablation procedure, an air leak occurred which led to an air embolism and transient st elevation.There were no issues with the device during prep; however, air was noted to be leaking from the hemostatic valve when pulling back after transseptal.The physician continued to use the device.Later in the procedure while exchanging the pfa catheter to the mapping catheter, the patient experienced transient st elevation which the physician believed to be linked to the defective sheath.The sheath was aspirated twice with a 20cc syringe.Patient was discharged.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h11.One 13f agilis steerable introducer sheath and dilator were received for evaluation.Functional testing confirmed a leak in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing was noted in the side wall of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.A corrective action was initiated to investigate the failure mode of the agilis leak.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 13F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ABBOTT MEDICAL (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22860634
• Report Number: 2182269-2025-00062
• Device Sequence Number: 7632226
• Product Code: DYB
• UDI-Device Identifier: 05415067051844
• UDI-Public: (01)05415067051844(10)10793133(17)280229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K243493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SI-1371-L
• Device Catalogue Number: SI-1371-L
• Device Lot Number: 10793133
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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: Unknown