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

Model Number	A-FASE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was published in theeuropean heart journal - case reports 8.2 oxford university press.(feb 1, 2024) in an article titled "successful ablation of purkinje ectopy¿triggered ventricular fibrillation storm in a patient with orthotopic heart transplantation and severe sars-cov-2 pneumonia: a case report"; m.K h a la p h e t a l et al.The patient experienced heart block.A 41-year-old man with an orthotopic heart transplantation (htx) in 2014 due to non-ischemic dilated cardiomyopathy, recently diagnosed with and treated for sars-cov-2 pneumonia, was referred to our centre (see supplementary material online, figure s1).The patient had experienced vf storm requiring prolonged cardiopulmonary resuscitation (cpr) for 50 min and >20 external defibrillations within 24 h.Despite administration of antiarrhythmic drugs (amiodarone), sedation with propofol and mechanical respiration finally led to stabilization of the rhythm.Upon admission to our centre, the patient experienced another vf storm episode, requiring cpr and another 11 defibrillations.Despite our best efforts, the vf episodes did not respond to the measures taken, which involved substitution of electrolytes (potassium, magnesium), administration of i.V.Antiarrhythmic drugs (amiodarone, beta-blocker, lidocaine), sedation (midazolam), drugs (amiodarone, beta-blocker, lidocaine), sedation (midazolam), overdrive pacing (increasing pacing rate to 90/min), and repetitive electrical defibrillations.After multiple attempts aiming for hemodynamic stabilization failed, the patient was stabilized through sedation and mechanical respiration.After the procedure, the patient was monitored continuously, and no pvcs were observed.However, following ablation, a left bundle branch block occurred with a qrs duration of 135 ms was noted.There were no immediate or late complications related to the ablation procedure.Antiarrhythmic agents were stopped after the ablation procedure, and a subcutaneous implantable cardioverter defibrillator (icd) was implanted.Of note, qrs duration normalized the day after ablation.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
Additional Manufacturer Narrative
Corrected data: d1, d2b, d4, g3, h2, h4.
Event or Problem Description
Add information received revealed the tacticath was not used in the procedure, but a flexability was.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 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 heart block remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18913382
• Report Number: 3008452825-2024-00146
• Device Sequence Number: 6825948
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: (01)05415067020062(10)8530927(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2025
• Device Model Number: A-FASE-DF
• Device Lot Number: 8530927
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/09/2024; Not provided
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/09/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2022
• 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 Age: 41 YR
• Patient Sex: Male