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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the second volt pulsed field ablation procedure in the la, air was aspirated from the sheath and st elevation was noted on ecg after the volt catheter was inserted.The agilis sheath was replaced and the volt catheter was inserted straight with the agilis handle below patient level.Air was aspirated from the second sheath as well.There was no further st elevation.The physician was able to turn the agilis angle with the irrigation port 360 degrees while aspirating with a 2 ml syringe to reduce vacuum pressure.No intervention was performed.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore, the primary di number is provided (d4), but full udi information is not available.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the batch record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident of a leak could not be conclusively determined.

• 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: 25175365
• Report Number: 2182269-2026-00253
• Device Sequence Number: 10567325
• Product Code: DYB
• UDI-Device Identifier: 05415067050182
• UDI-Public: 05415067050182
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/14/2026

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
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• 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
• Patient Sex: Unknown