MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPICARDIAL CATHETER SYSTEM, AGILIS¿ NXT STEERABLE INTRODUCER, 40CM SMALL CURL DU; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	G402047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Related manufacturing reference 3005334138-2019-00420 during a ventricular tachycardia ablation procedure a cardiac perforation occurred.During epicardial access with the agilis introducer and advisor hd grid catheter, the heart was perforated.To stabilize the patient and repair the perforation, sternotomy was performed and the patient was put on cardiopulmonary bypass for open heart surgery.The user elected not to perform the scheduled ablation procedure.There were no performance issues with any abbott device.
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.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: EPICARDIAL CATHETER SYSTEM, AGILIS¿ NXT STEERABLE INTRODUCER, 40CM SMALL CURL DU
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8850742
• Report Number: 2182269-2019-00107
• Device Sequence Number: 10835312
• Product Code: DRF
• UDI-Device Identifier: 05414734216418
• UDI-Public: 05414734216418
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 10/31/2020
• Device Model Number: G402047
• Device Catalogue Number: G402047
• Device Lot Number: 6792296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/09/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID MAPPING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 123