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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fracture that was noted during analysis.During an svt procedure, it was reported that following transseptal access, the sheath tip appeared deformed on fluoroscopy.The sheath had been used to obtain transseptal access and the access was noted to be difficult, requiring quite a bit of force to transition the sheath tip into the left atrium.The dilator was removed and the rf ablation catheter was advanced into the sheath, however, the physician was unable to get the catheter through the sheath tip easily.Fluoroscopy revealed a defect near the tip.The sheath was exchanged over a wire.The issue was resolved and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f agilis steerable introducer sheath and dilator were received for evaluation.The sheath was bent at 0.3¿ and the internal braiding of the sheath was protruding from the bend.No other visual anomalies were noted.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25315286
• Report Number: 3008452825-2026-00289
• Device Sequence Number: 9985816
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: (01)05414734206105(10)11217461(17)281231
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 11217461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• 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: 05/19/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2026
• 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