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

Model Number	A-FASE-FJ
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/28/2021
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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a typical cavo-tricuspid isthmus (cti) atrial flutter ablation procedure, a steam pop and pericardial effusion occurred.While ablating a line from the tricuspid valve towards the inferior vena cava no impedance rise was noted, but a there was a faint audible steam pop.The lesion was completed successfully but a few minutes later the patient became hypotensive.An echocardiogram revealed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.

• Brand Name: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 12056873
• Report Number: 3008452825-2021-00353
• Device Sequence Number: 3647842
• Product Code: OAD
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 11/30/2023
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 7778658
• 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: 05/28/2021
• Initial Report FDA Received Date: 06/24/2021
• 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
• Patient Weight: 110