MAUDE Adverse Event Report: ABBOTT AGILIS; INTRODUCER, CATHETER

Model Number AGILIS (ABBOTT)

Device Problem Entrapment of Device (1212)

Patient Problems Atrial Fibrillation (1729); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

During an electrophysiology (ep) study, the patient went into af and it was decided to do a cryoablation procedure.After obtaining transseptal access and attempting to exchange sheaths with a guidewire, the wire was entrapped within the left ventricle (stuck on a chordal apparatus of the mitral valve).The patient was eventually taken to the operating room to remove the wire.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AGILIS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17489163
• MDR Text Key: 320689763
• Report Number: MW5121812
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: AGILIS (ABBOTT)
• Patient Sequence Number: 1