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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulsed field ablation procedure, air aspirated from the valve when the volt catheter was inserted.The sheath was replaced but the same issue occurred.The sheath was replaced again and the procedure was completed with no adverse consequences to the patient.The sheaths were flushed properly with each flush performed before introducing the volt catheter and only blood was aspirated, with no bubbles.Air was noted after the volt catheter was inserted.As soon as the volt was inserted, large air bubbles were aspirated.The issue disappeared when the volt was removed.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11 one 13f agilis steerable introducer sheath was 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 that is consistent with a known design related issue.A separate tear was also noted at one side of the insertion slit and its cause could not be determined based on the available evidence.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the slit tear remains unknown.

• 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; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24402698
• Report Number: 2182269-2026-00080
• Device Sequence Number: 8269842
• Product Code: DYB
• UDI-Device Identifier: 05415067051844
• UDI-Public: (01)05415067051844(10)10983853(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: SI-1371-L
• Device Catalogue Number: SI-1371-L
• Device Lot Number: 10983853
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 13F
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 110 KG