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 Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 13f agilis steerable introducer sheath was received for evaluation, and the reported event of a deflection issue was confirmed.The sheath did not deflect in one direction due to the pull ring being pulled out of position and the detachment of one of the pull wires from the pull ring at the distal end of the sheath.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
This report is to advise of a displacement of the pull ring at the distal end of the sheath.During the af procedure with volt, it was noted that the agilis could no longer be maneuvered after ablating 3 of the 4 veins.To finish ablating the right inferior pulmonary vein, a tactiflex catheter was used to complete the procedure as there was no replacement agilis on hand to use with the volt catheter.The procedure was completed successfully with no adverse patient 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 ; 6517565400
• MDR Report Key: 25366854
• Report Number: 2182269-2026-00333
• Device Sequence Number: 10049418
• Product Code: DYB
• UDI-Device Identifier: 05415067051851
• UDI-Public: (01)05415067051851(10)11038798(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 06/02/2026

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: 11038798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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