MAUDE Adverse Event Report: ABBOTT MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 13F; Introducer, catheter

Model Number	SI-1371-S
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 13f agilis sheath and dilator were received for investigation.The dilator had been perforated proximal to the distal tip.The dilator and sheath were flushed with fluid and the dilator was inserted into the sheath; no resistance or anomalies were noted.A needle/stylet assembly from current inventory was inserted and advanced through the dilator/sheath assembly; however, the needle could not advance past the location of the perforation.No damage was noted on the returned sheath.The damaged dilator tip was not able to be replicated with dilators from current inventory.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the dilator bend and perforation remains unknown.
Event or Problem Description
This report is to advise of a punctured dilator that was noted during analysis.During the atrial fibrillation procedure, the tip of the dilator was bent during the passage of the brk needle.The patient anatomy was unusual and the curvature of the vein complicated access for the transseptal puncture.The sheath was replaced and the procedure was completed with no adverse patient consequences.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 13F
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ABBOTT MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25107928
• Report Number: 2182269-2026-00271
• Device Sequence Number: 15784559
• Product Code: DYB
• UDI-Device Identifier: 05415067050182
• UDI-Public: (01)05415067050182(10)11053890(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K243493
• 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
• Report Date (Section B): 05/06/2026

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: SI-1371-S
• Device Catalogue Number: SI-1371-S
• Device Lot Number: 11053890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• Patient Sex: Unknown