MAUDE Adverse Event Report: ABBOTT MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 8.5F; INTRODUCER, CATHETER

Model Number	G408324
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the vt procedure, a hole in the sheath at the tip prevented transseptal puncture.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 8.5f agilis steerable introducer sheath and dilator were received for evaluation.The sheath vacuum relief hole (vrh) had been stretched and bent.The returned dilator was inserted and withdrawn through the entire length of sheath with no resistance noted; the dilator exited the sheath distal tip.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported dilator insertion difficulty remains unknown.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE 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 ; 6517565400
• MDR Report Key: 24941553
• Report Number: 3008452825-2026-00204
• Device Sequence Number: 12178458
• Product Code: DYB
• UDI-Device Identifier: 05414734206150
• UDI-Public: (01)05414734206150(10)11246348(17)290131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081645
• 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,Followup
• Report Date (Section B): 05/20/2026

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: G408324
• Device Catalogue Number: G408324
• Device Lot Number: 11246348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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