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

Model Number	A701125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a premature ventricular contractions procedure, the patient suffered cardiac arrest due to arrhythmia requiring resuscitation.Rf energy was delivered in the site of the earliest signal, identified as mitral aortic region.The flexability catheter was used with the following ablation parameters: 30w, 43ºc, 150 ohms, 13ml/min.After ablation, the physician waited 5 minutes to see if another pvc would occur before starting further ep study protocols (measure hv interval ~53ms, wenckebach point).After this, isoproterenol was used to increase patient's heart frequency and to test whether the ablation was successful.No pvcs were observed, but when the effect of isoproterenol was decreasing, ventricular fibrillation started and the patient had no palpable pulse.Cpr was performed and several shocks were delivered with an external defibrillator.Sinus rhythm was reestablished after 30 minutes, the patient was stabilized and went to icu for recovery.Later that day the patient had a spasm of the anterior descendent coronary artery, which caused ventricular fibrillation.On the same day, an angioplasty was performed.
Event or Problem Description
During a premature ventricular contractions procedure, the patient suffered cardiac arrest due to arrhythmia requiring resuscitation.Rf energy was delivered in the site of the earliest signal, identified as mitral aortic region.The flexability catheter was used with the following ablation parameters: 30w, 43ºc, 150 ohms, 13ml/min.After ablation, the physician waited 5 minutes to see if another pvc would occur before starting further ep study protocols (measure hv interval ~53ms, wenckebach point).After this, isoproterenol was used to increase patient's heart frequency and to test whether the ablation was successful.No pvcs were observed, but when the the effect of isoproterenol was decreasing, ventricular fibrillation started and the patient had no palpable pulse.Cpr was performed and several shocks were delivered with an external defibrillator.Sinus rhythm was reestablished after 30 minutes, the patient was stabilized and went to icu for recovery.On the same day, an angioplasty was performed.The patient had a spasm of the anterior descendent coronary artery.It is unknown when the spasm of the anterior descendent coronary artery occurred, but the doctor believes that it was the cause of the ventricular fibrillation, so it is thought to have occurred during the procedure, but it was only diagnosed in a catheterization later that day.
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 arrest and arrhythmia remain unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F
• Common Device Name: 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15811986
• Report Number: 3008452825-2022-00675
• Device Sequence Number: 5501538
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: 05415067011114
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2023

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: 12/31/2024
• Device Model Number: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 8298155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 01/07/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 11/21/2022; 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown