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

Model Number	G408324
Medical Device Problem Codes	Peeled/Delaminated (1454); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After atrial fibrillation procedure, the health care provider removed the sheath from the patient and there was a fiber contained in the sheath.We pulled it off and the patient is stable and the procedure was completed successfully.There was no report of resistance during insertion of the needle into the sheath.It is thought that the stylet was not used.The needle was not reshaped.It is unknown what could have caused the fiber.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8.5f agilis steerable introducer sheath was received for evaluation.One strip of delaminated jacket liner was returned with the sheath measuring 33.0¿ long.The reported ¿fiber contained in the sheath¿ returned with the device was confirmed to be a portion of the sheath jacket lining.The sheath was dissected and a section of the jacket liner from the interior of the sheath was found delaminated, consistent with the reported issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the jacket liner delamination remains unknown.Communication from the field states the stylet was not used.Agilis¿ nxt steerable introducer instructions for use (ifu) states, ¿during insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly.Failure to use the stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly or skiving of material from the inner surface of the dilator.".

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23346918
• Report Number: 3008452825-2025-00519
• Device Sequence Number: 7750889
• Product Code: DYB
• UDI-Device Identifier: 05414734206150
• UDI-Public: (01)05414734206150(10)10862130(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081645
• 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): 12/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G408324
• Device Catalogue Number: G408324
• Device Lot Number: 10862130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown