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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, the sheath with the dilator was inserted into the patient¿s body using the wire supplied with farawave nav, and resistance was noted in the blood vessel.Therefore, the sheath along with the dilator was withdrawn completely from the patient.When checking the device, the tip of the dilator was found to be bent.When inserting the second agilis 13fr into the patient's body, resistance was noted in the blood vessel again.When contrast imaging was performed through the sheath¿s flush port, dissection of the femoral vein was noted.The agilis was left in place for hemostasis, and the replacement sheath was inserted through the contralateral femoral vein to perform the procedure.The procedure was completed with no further issues.After completion of the procedure, and removal of the sheath, contrast imaging was performed again, and it was confirmed that there was no enlargement of the dissection or hematoma, so the patient was returned to recovery without intervention needed and has since been discharged.There were no alleged performance issues with any abbott devices.
Additional Manufacturer Narrative
One 13f agilis steerable introducer sheath and dilator were received for evaluation.No visual anomalies were noted on the returned device.No gap was noted at the dilator/sheath transition when the dilator was advanced through the returned sheath.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported vascular dissection remains unknown.
Event or Problem Description
During an atrial fibrillation procedure, the agilis sheath with the dilator was inserted into the patient's body using the non-abbott wire supplied with the non-abbott (boston scientific) farawave nav catheter, and resistance was noted in the blood vessel.Therefore, the agilis sheath along with the dilator was withdrawn completely from the patient.When checking the device, the tip of the dilator was found to be bent.When inserting the second agilis sheath into the patient's body, resistance was noted in the blood vessel again.When contrast imaging was performed through the agilis sheath flush port, dissection of the femoral vein was noted.The agilis sheath was left in place for hemostasis, and the replacement sheath was inserted through the contralateral femoral vein to perform the procedure.The procedure was completed with no further issues.After completion of the procedure, and removal of the agilis sheath, contrast imaging was performed again, and it was confirmed that there was no enlargement of the dissection or hematoma, so the patient was returned to recovery without intervention needed and has since been discharged.There were no alleged performance issues with any abbott devices.The physician commented that the non-abbott wire included with the non-abbott (boston scientific) farawavenav catheter was relatively soft and could not be firmly maintained, which may have resulted in pressure being applied toward the vessel wall during sheath insertion.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h11.

• 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: 25250930
• Report Number: 2182269-2026-00228
• Device Sequence Number: 9724861
• Product Code: DYB
• UDI-Device Identifier: 05415067050182
• UDI-Public: (01)05415067050182(10)11018771(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/13/2026

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-S
• Device Catalogue Number: SI-1371-S
• Device Lot Number: 11018771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 71 KG