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

Model Number	408310
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation for an af procedure using rf ablation, the valve was not working in the agilis introducer allowing air to pass through when flushing.To resolve, the sheath was exchanged.The procedure was completed with no adverse patient consequences.
Event or Problem Description
Additional information confirmed that the leak occurred prior to contact with the patient, making the event not reportable.A leak that occurred outside the patient may require troubleshooting or replacement of the device, which is likely to resolve the issue and would not result in serious injury or death to the patient.During device preparation, prior to patient contact, for an af procedure using rf ablation, the valve was not working in the agilis introducer allowing air to pass through when flushing.To resolve, the sheath was exchanged.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.Additional information confirmed that the leak occurred prior to contact with the patient, making the event not reportable.A leak that occurred outside the patient may require troubleshooting or replacement of the device, which is likely to resolve the issue and would not result in serious injury or death to the patient.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F
• 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: 23542682
• Report Number: 3008452825-2025-00586
• Device Sequence Number: 18571728
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: (01)05414734206105(10)10758931(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K061363
• 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): 12/08/2025

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: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 10758931
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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