MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 8.5F; INTRODUCER, CATHETER

Model Number G408324

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemothorax (1896); Cardiac Perforation (2513)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference: 2182269-2020-00050, 3008452825-2020-00255, 3008452825-2020-00257, 2182269-2020-00051.During ventricular tachycardia mapping in the left ventricle, a pericardial effusion occurred.After approximately an hour of mapping, using transseptal approach, the patient became hypotensive.An ultrasound confirmed a pericardial effusion for which a pericardiocentesis was administered.An additional ultrasound confirmed a hemothorax on the left side of the thorax, which was treated with a thorax drain.The cause and location of the pericardial effusion remains unknown, however it was noted the transseptal puncture was difficult.The patient was stable with minimal use of catecholamines and transferred to the icu.There were no performance issues with any abbott device.

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 effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10098882
• MDR Text Key: 193052460
• Report Number: 3008452825-2020-00256
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206150
• UDI-Public: 05414734206150
• Combination Product (y/n): N
• PMA/PMN Number: K081645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: G408324
• Device Catalogue Number: G408324
• Device Lot Number: 7234105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR; SUPREME¿ ELECTROPHYSIOLOGY CATHETER; TRANSSEPTAL NEEDLE, BRK SERIES
• Patient Outcome(s): Other