MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/06/2019
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 instructions for use, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
During a right ventricular outflow tract ablation procedure, a cardiac perforation occurred.While mapping in the right ventricle outflow tract in the anterolateral region, the catheter was attempted to be moved to the region of interest but it appeared outside the navx anatomy.The patient became hypotensive and dizzy.Fluoroscopy and echocardiogram were performed, revealing a perforation.A pericardiocentesis was performed and medication was given to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE F
• 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: 8347744
• Report Number: 3008452825-2019-00071
• Device Sequence Number: 1598572
• Product Code: OAD
• UDI-Device Identifier: 05415067011503
• UDI-Public: 05415067011503
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/18/2019

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: 06/30/2020
• Device Model Number: A701158
• Device Catalogue Number: A701158
• Device Lot Number: 6058234
• 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: 02/06/2019
• Initial Report FDA Received Date: 02/18/2019
• 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: Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60