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 Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fractured guidewire noted during analysis.
Additional Manufacturer Narrative
One 8.5f agilis steerable introducer sheath and dilator were received for evaluation.The guidewire assembly was also returned.The guidewire was noted to be bent and unraveling 0.8¿ from the proximal end.Resistance was noted when the returned guidewire was inserted into the dilator due to the aforementioned damage to the guidewire.Both the dilator distal tip inside diameter and guidewire outside diameter measurements were within specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported guidewire damage and insertion difficulty remains unknown.

• 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: 22575407
• Report Number: 3008452825-2025-00365
• Device Sequence Number: 9637767
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: (01)05414734206099(10)10495251(17)270831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/23/2025

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: 10495251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• 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: 07/09/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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