MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER, SENSOR ENABLED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number A-FASE-FJ

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related mfr no.2182269-2020-00094; 2182269-2020-00093.During a right ventricular outflow tract premature ventricular contraction ablation, a pericardial effusion was observed and the procedure was cancelled.While ablating the anterior aspect, hypotension was noted, and a pericardial effusion was found via ultrasound.The case was abandoned, and a pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

An event of pericardial effusion was reported.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.Per the ifu, vascular perforation is an inherent risk of any electrode placement.  .

• Brand Name: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 10800515
• MDR Text Key: 215025634
• Report Number: 3008452825-2020-00567
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 7559544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 112