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 Codes	Death (1802); Cardiac Perforation (2513)
Date of Event	03/14/2019
Type of Reportable Event	Death
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 ref: 9680001-2019-00052, 3005334138-2019-00174, 3005334138-2019-00175.During a premature ventricular contraction ablation procedure, a pericardial tamponade occurred and the patient expired.Following geometry creation, ablation was performed in the left pulmonary veins (pv) and the patient became hypotensive.An ultrasound was performed, and ablation continued in the right pv spontaneous induction from an atrial tachycardia.The decision was made to ablate an anterior block line and the patient became hypotensive again and an ultrasound revealed a pericardial tamponade.A pericardiocentesis was performed, however, the blood pressure did not increase and cardiopulmonary resuscitation (cpr) was started.After one hour of cpr without any improvement, cpr was stopped, and the patient expired.There were no performance issues with any abbott devices.The patient expired due to electrical mechanical decoupling caused by pericardial tamponade during ablation of a left atrial flutter.
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 incident could not be conclusively determined.
Additional Manufacturer Narrative
Corrected data.
Event or Problem Description
During a pulmonary vein isolation ablation procedure.

• 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: 8465811
• Report Number: 2182269-2019-00034
• Device Sequence Number: 1628487
• Product Code: DYB
• UDI-Device Identifier: 05414734206136
• UDI-Public: 05414734206136
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061363
• 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,Followup
• Report Date (Section B): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: G408320
• Device Catalogue Number: G408320
• Device Lot Number: 6733190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 05/01/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/25/2019; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR CATHETER; SWARTZ INTRODUCER; TACTICATH ABLATION CATHETER; ADVISOR CATHETER; SWARTZ INTRODUCER; TACTICATH ABLATION CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Weight: 85