MAUDE Adverse Event Report: Abbott Medical Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Small Curl, 8.5F; Introducer, Catheter

Model Number	408309
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a sideport detachment found during analysis.During device preparation for an af procedure, the tip of the sheath was noted to be torn.The device was exchanged and the procedure was completed with no adverse patient health consequences.
Additional Manufacturer Narrative
One 8.5f agilis steerable introducer sheath and dilator were received for evaluation.The reported event of introducer tip tearing could not be confirmed.No issues were found with the introducer tip.However, the side port tubing was disconnected from the sheath.Further investigation revealed the sideport tubing was partially occluded.The occlusion was determined to be solvent used in the manufacturing process for sideport tubing attachment.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No nonconformances associated with the reported event were identified.

• Brand Name: Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Small Curl, 8.5F
• Common Device Name: Introducer, Catheter
• Manufacturer (Section D): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50927309
• Report Number: 3008452825-2026-00524
• Device Sequence Number: 10734694
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: (01)05414734206099(10)10872692(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K061363
• 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): 09/28/2026

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: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 10872692
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2026
• 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: 09/25/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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