MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS NXT STEERABLE INTR. 8.5F, SMALL CURL, 71CM; INTRODUCER, CATHETER

Model Number	G408320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported cardiac perforation could not be conclusively determined as the pericardial septum was inadvertently punctured.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During an atrial fibrillation ablation procedure a cardiac perforation occurred.Following transseptal puncture with an sl0 sheath an agilis was inserted.While inserting the agilis through the transseptal puncture the pericardial septum was inadvertently punctured.Echocardiography confirmed an effusion and the procedure was stopped to monitor the effusion.A pericardiocentesis was required to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: AGILIS NXT STEERABLE INTR. 8.5F, SMALL CURL, 71CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9310256
• Report Number: 2182269-2019-00238
• Device Sequence Number: 2131745
• Product Code: DYB
• UDI-Device Identifier: 05414734206136
• UDI-Public: 05414734206136
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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 Expiration Date: 02/28/2022
• Device Model Number: G408320
• Device Catalogue Number: G408320
• Device Lot Number: 6903237
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention