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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction

• 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: 50159157
• Report Number: 2182269-2026-00516
• Device Sequence Number: 16110223
• Product Code: DYB
• UDI-Device Identifier: 05415067051851
• UDI-Public: (01)05415067051851(10)11099034(17)280930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K243493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 11099034
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2026
• 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: 07/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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