MAUDE Adverse Event Report: Abbott Medical Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Small Curl, 13F; Introducer, Catheter

Model Number	SI-1371-S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulsed field ablation atrial fibrillation procedure, air was aspirated from the agilis 13f sheath upon insertion of the volt catheter.The catheter was removed and the agilis sheath was aspirated with no issue.A second attempt to insert the volt catheter was made, but the issue was not resolved.The sheath was exchanged for a second agilis 13f sheath, but upon insertion of the volt catheter, air was aspirated.An additional attempt was made to insert to the catheter, but the issue was not resolved.The volt catheter was exchanged, but the issue was not resolved.The sheath was exchanged for a third agilis 13f sheath, and the procedure was completed with no adverse consequences to the patient.

• Brand Name: Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Small 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 ; +1(651)756-5400
• MDR Report Key: 50885488
• Report Number: 2182269-2026-00566
• Device Sequence Number: 13438005
• Product Code: DYB
• UDI-Device Identifier: 05415067050182
• UDI-Public: (01)05415067050182(10)11302160(17)290228
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K243493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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-S
• Device Catalogue Number: SI-1371-S
• Device Lot Number: 11302160
• Was Device Available for Evaluation?: No
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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