MAUDE Adverse Event Report: ABBOTT MEDICAL, COSTA RICA LTDA AGILIS¿ NXT STEERABLE INTRODUCER; INTRODUCER, CATHETER

Model Number	G408321
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product's lot number was unable to be obtained, therefore the primary di number is provided (d4), but full udi information is not known.
Event or Problem Description
During ablation procedure, the agilis perforated the iliac vein.There was difficulty inserting the agilis, the sheath had kinked at the iliac vein above the pelvic rim.The sheath was removed and the guidewire was left in.Shortly after, the blood pressure dropped and a venogram confirmed extravasation at the iliac vein.The patient required stenting to resolve the issue.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.An event of a perforation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 23020148
• Report Number: 3008452825-2025-00451
• Device Sequence Number: 21288219
• Product Code: DYB
• UDI-Device Identifier: 05414734206143
• UDI-Public: 05414734206143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G408321
• Device Catalogue Number: G408321
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown