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	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 13f agilis steerable introducer sheath was received for evaluation.The dilator was also returned.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.No nonconformances associated with the reported event were identified.
Event or Problem Description
This report applies to the agilis introducer that experienced the steering / deflection issue and is to advise of a displacement of the pull ring at the distal end of the sheath.During an atrial fibrillation pfa procedure, it was noted to be difficult to reach the right inferior pulmonary veins (ripv).All 3 other veins were targeted with ease.The physician noted that the sheath stopped steering as expected, thinking the pull wire may be broken.The sheath was replaced and the catheter and non-abbott guidewire (starter guidewire by boston scientific) were also removed.The procedure was finished without ablation in the ripv.The patient was stable.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25367437
• Report Number: 2182269-2026-00348
• Device Sequence Number: 9808689
• Product Code: DYB
• UDI-Device Identifier: 05415067051851
• UDI-Public: (01)05415067051851(10)11067477(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: 11067477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• 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: 09/30/2025
• 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