MAUDE Adverse Event Report: Abbott Medical Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Medium Curl, 8.5 F; Introducer, Catheter

Model Number	408310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the pvc procedure, the coronary sinus was perforated.Mapping was performed with the agilis sheath and a decapolar catheter.The decapolar catheter was slipped back into the agilis and then the physician believes that the agilis perforated the coronary sinus.A venogram showed contrast in the pericardial space.The procedure was abandoned and protamine administered.No intervention was performed.The patient remained hemodynamically stable and is recovering.There were no product performance issues.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident of a coronary sinus perforation could not be conclusively determined.

• Brand Name: Agilis¿ NxT Steerable Introducer Dual-Reach¿ 71 cm Sheath, Medium Curl, 8.5 F
• Common Device Name: Introducer, Catheter
• Manufacturer (Section D): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): Abbott Medical; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50147046
• Report Number: 3008452825-2026-00425
• Device Sequence Number: 16095088
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: (01)05414734206105(10)11394546(17)290430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 11394546
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2026
• 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
• Patient Sex: Unknown