MAUDE Adverse Event Report: ABBOTT MEDICAL AGILIS NXT INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was published in the journal of arrhythmia in an article titled, "clinical insights into the role of bepridil in recurrence prevention after ablation of persistent atrial fibrillation"; moyuru hirata md1, 2025;41:e70083, https://doi.Org/10.1002/joa3.70083.This retrospective study included 232 consecutive peraf patients who underwent af ablation between 2014 and 2019.Among them, 162 received bepridil for 3 months post-ablation (bepridil group), while 70 received no antiarrhythmic drugs (no-aads group).Baseline characteristics, procedural details, and outcomes were compared.Kaplan¿meier analysis and cox regression models were used to evaluate af/atrial tachycardia (at) recurrence, with bepridil use treated as a time-dependent covariable.There was 1 event of pseudoaneurysm.
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AGILIS NXT INTRODUCER, UNKNOWN
• 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 ; 6517565400
• MDR Report Key: 22216677
• Report Number: 3008452825-2025-00284
• Device Sequence Number: 8157893
• Product Code: DYB
• UDI-Device Identifier: 05415067000255
• UDI-Public: 05415067000255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SWARTZ¿ INTRODUCER.; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE.
• Patient Sex: Unknown