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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, optical and steering issues occurred causing a delay.The mapping for the at source was first done with the advisor hd grid catheter and then ablation was done with the tactiflex catheter on the ra free wall at around 8 o'clock with an agilis sheath.The tachycardia subsided but then recovered.The tactiflex catheter was swapped with the advisor hd grid catheter again for re-mapping, and then the tactiflex was reinserted.With the tactiflex inserted, when trying to rotate to a particular curve, a snap was felt, and the agilis sheath would not deflect bi-directionally anymore.In addition, the force was not displayed and showed as "---" on the panel on ensite x.The agilis was replaced.The ablation catheter was reseated and the tactisys was restarted with no resolution.The tactiflex was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 one 8.5f agilis steerable introducer sheath was received for evaluation.The sheath was unable to deflect in one direction due to the detachment of one of the pull wires from the pull ring at the distal end of the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Abbott is continuing to monitor this issue.

• 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 ; 6517565400
• MDR Report Key: 22792818
• Report Number: 3008452825-2025-00401
• Device Sequence Number: 8789524
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: (01)05414734206099(10)10558654(17)270930
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/09/2025

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: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 10558654
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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