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

Model Number	A-FASE-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Cardiac Perforation (2513)
Date of Event	09/01/2021
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. .
Event or Problem Description
Following a ventricular tachycardia ablation procedure, the patient experienced transient ischemic attack (tia).A head ct scan performed on (b)(6) 2021 a minute hypodensity consistent with a tia.Additionally, the patient experienced a transitory double vision episode.The patient was treated with anticoagulant therapy.A ct scan performed on (b)(6) 2021, documented stability of the lesion and the event resolved with no further complications to the patient.There were no performance issues with any abbott devices.
Event or Problem Description
Following a ventricular tachycardia ablation procedure, the patient experienced transient ischemic attack (tia).A head ct scan performed on (b)(6) 2021 a minute hypodensity consistent with a tia.Additionally, the patient experienced a transitory double vision episode.The patient was treated with anticoagulant therapy.A ct scan performed on (b)(6) 2021, documented stability of the lesion and the event resolved with no further complications to the patient.There were no performance issues with any abbott devices.Per clinical update: during an additional procedure that took place in july 2022, an effusion occurred requiring pericardiocentesis and a blood transfusion.The physician stated that the effusion was related to the ablation procedure, but it's unknown if an abbott device contributed to the event.
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.

• 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; 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: 12546100
• Report Number: 3008452825-2021-00474
• Device Sequence Number: 10980976
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: 05415067020031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 02/29/2024
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 7871157
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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: Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 60 KG