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-F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/28/2018
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 cardiac perforation may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Following an ventricular tachycardia ablation procedure a pericardial effusion occurred.At the end of the procedure echography confirmed an effusion requiring a pericardiocentesis.The effusion occurred due to the user inadvertently advancing the ablation catheter in the ventricle during the procedure.There were no patient symptoms noted.There were no alleged malfunction with any abbott device.

• 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: 8254229
• Report Number: 3008452825-2019-00021
• Device Sequence Number: 1607401
• Product Code: OAD
• UDI-Device Identifier: 05415067020048
• UDI-Public: 05415067020048
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 12/31/2020
• Device Model Number: A-FASE-F
• Device Lot Number: 6284788
• 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: 12/28/2018
• Initial Report FDA Received Date: 01/16/2019
• 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 Age: 70 YR
• Patient Weight: 90