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

Model Number	SI-1371-M
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, it was noted that the iliac vein was perforated which resulted in a balloon being placed to seal the perforation.Access was gained in both the right and left femoral veins.The cs catheter was inserted through the left femoral vein with no issue and positioned in the coronary sinus.An ice catheter was inserted through the right femoral vein access into the ra with no issue.The amplatz super stiff 0.035¿ wire was inserted through the right femoral vein into the svc with no issue either.The short sheath was removed from the right femoral access and an agilis 13f with the dilator over the wire was advanced.While advancing, resistance was met.A few attempts were made to maneuver past the resistance with no resolution.The amplatz wire, agilis 13f, and dilator were removed from the patient.After withdrawing, the resistance was met again.Ice was used to visualize the area of resistance in the groin.The ice catheter was removed, and the short sheath was inserted again.Contrast was inserted through the right femoral sheath under fluoroscopy.Contrast was seen exiting the out the right side of the right iliac vein into the extra-venous space and travelling up the ivc and down the left iliac vein.A balloon was placed to seal the perforation.The patient is stable.The physician alleges that the agilis dilator perforated the iliac vein.It was noted that the stiffness of the agilis dilator was an issue and contributed to the adverse event occurring.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM 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: 25798398
• Report Number: 2182269-2026-00410
• Device Sequence Number: 17614755
• Product Code: DYB
• UDI-Device Identifier: 05415067051851
• UDI-Public: (01)05415067051851(10)11275158(17)290131
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K243493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SI-1371-M
• Device Catalogue Number: SI-1371-M
• Device Lot Number: 11275158
• 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: 06/19/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2026
• 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: Required Intervention
• Patient Sex: Female