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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a pvi pfa procedure, communication and positioning issues resulted in the cancellation of the procedure.After a few pfa deliveries, it was noted that electrode 3 turned invalid (yellow) and did not turn back, even after resetting the baseline.After a while the same happened with electrode 7.It was also noted that the pull mechanism on the sheath stopped working.The catheter and sheath were replaced but the second catheter did not collect any geometry and it was not possible to advance the catheter out of the sheath without extra force.The physician stopped the procedure at this point.There were no adverse consequences for the patient.

• 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: 25264492
• Report Number: 2182269-2026-00324
• Device Sequence Number: 9733776
• Product Code: DYB
• UDI-Device Identifier: 05415067051851
• UDI-Public: (01)05415067051851(10)11163637(17)281130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/23/2026

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-M
• Device Catalogue Number: SI-1371-M
• Device Lot Number: 11163637
• 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: 05/11/2026
• Initial Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2025
• 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