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 Codes	Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia radiofrequency procedure, there was a delay.The catheter could not be inserted into the patient's coronary sinus.After removal, it was noted that the tip of the catheter would not bend.The catheter was replaced and that issue was resolved.In addition, the sheath was bent clockwise to align with the axis of rotation.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6, h11.One 8.5f agilis steerable introducer sheath was received for evaluation.When actuated in both directions, resistance was noted and the sheath was no longer able to deflect.The handle was opened and one of the threaded inserts was noted to be out of position and fractured, consistent with the deflection issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the displaced threaded insert remains unknown.
Event or Problem Description
During the supraventricular tachycardia radiofrequency procedure, there was a delay.The catheter could not be inserted into the patient's cs.After removal, it was noted that the tip of the catheter would not bend and an s curve was also observed.The catheter was replaced and that issue was resolved.In addition, the sheath would not deflect when bending in the forward direction but deflected in the reverse.The sheath was replaced and the procedure was completed with no adverse consequences 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: 23513579
• Report Number: 3008452825-2025-00570
• Device Sequence Number: 18547215
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: (01)05414734206105(10)10668213(17)271231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/08/2026

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: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 10668213
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Patient Sex: Unknown