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

Model Number	SI-1371-M
Medical Device Problem Codes	Difficult to Insert (1316); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
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 due to non-axial insertion of the dilator.A separate tear was observed at one side of the insertion slit; the cause of the slit tear could not be determined.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.An updated hemostasis seal was implemented in march 2026 to improve seal robustness.The complaint device associated with this event was manufactured prior to implementation of the updated hemostasis seal.
Event or Problem Description
During an atrial fibrillation procedure, an air leak was noted on the hemostasis valve of the agilis sheath after volt catheter insertion.Prior to volt catheter insertion, it was noted that there was increased resistance requiring more force than normal when inserting the dilator into the agilis sheath.After the volt catheter was inserted, an air leak was noted to be coming from the hemostasis valve.The agilis sheath was exchanged, and the procedure was completed with no adverse patient health consequences.

• Brand Name: Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Medium 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: 50410996
• Report Number: 2182269-2026-00531
• Device Sequence Number: 10489095
• Product Code: DYB
• UDI-Device Identifier: 05415067051851
• UDI-Public: (01)05415067051851(10)11256163(17)290131
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/24/2026

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-M
• Device Catalogue Number: SI-1371-M
• Device Lot Number: 11256163
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2026
• 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