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 Codes	Difficult to Insert (1316); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 13f agilis steerable introducer sheath was received for evaluation.The sheath was bent and fractured proximal to the distal tip.A volt catheter from current inventory was unable to be inserted past the location of the aforementioned damage.Functional testing was unable to be performed due to the aforementioned damage to the sheath.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing was noted in the side wall of the seal that is consistent with a known design-related issue.A separate tear was also noted at both sides of the insertion slit and its cause could not be determined based on available evidence.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The insertion difficulty is consistent with the sheath damage.The cause of the sheath damage remains unknown.The cause of the slit tear remains unknown.
Event or Problem Description
During the af procedure with volt, it was noted that it was difficult to introduce the volt catheter into the agilis.Only air was pulled out of the syringe when the volt was inserted into the agilis.It would not aspirate as expected.The agilis was the device that seemed to have air pulling into it.The agilis was replaced, which resolved the issue, and the procedure was completed with no adverse consequences to the patient.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25115796
• Report Number: 2182269-2026-00275
• Device Sequence Number: 9292948
• Product Code: DYB
• UDI-Device Identifier: 05415067050182
• UDI-Public: (01)05415067050182(10)11087717(17)280930
• 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): 05/07/2026

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: 11087717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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