MAUDE Adverse Event Report: ABBOTT MEDICAL 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 Codes	Air Embolism (1697); Arrhythmia (1721)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a premature ventricular contraction procedure, the sheath was leaking air which resulting in an air embolism and st elevation.At the start of mapping, with the mapping catheter in the sheath, st elevations appeared on the ecg.A coronary angiography was used to visualize the right coronary artery however nothing was noted.The sheath was rinsed again, a new map was started, and the st elevations disappeared over time.When mapping was finished, the mapping catheter was replaced with the ablation catheter.St elevations appeared again at the start of ablation.The ablation was then stopped and the coronary angiography was repeated.This time there were air bubbles in the right coronary artery.The sheath was replaced and the issues resolved.It is alleged that the sheath was leaking air.The procedure was then completed successfully with no further complications.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 8.5f agilis steerable introducer sheath was received for evaluation.A dilator from current inventory was inserted and removed from the sheath.The sheath was tested for leaks.An aspiration vacuum leak test was conducted; no air aspirated into the syringe.A pressure leak test (liquid method) was also conducted; no leaks were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak and subsequent air embolism and st elevation 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; 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; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22383658
• Report Number: 3008452825-2025-00319
• Device Sequence Number: 7138669
• Product Code: DYB
• UDI-Device Identifier: 05414734206150
• UDI-Public: (01)05414734206150(10)10249974(17)270228
• 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): 08/15/2025

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: G408324
• Device Catalogue Number: G408324
• Device Lot Number: 10249974
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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