MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVSE-DF10-F15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/14/2022
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 ifu, vascular perforation is an inherent risk of any electrode placement.  .
Event or Problem Description
During an atrial fibrillation ablation procedure, a cardiac tamponade was diagnosed via echocardiogram.Initially when starting to map the left atrium of the patient, the patient reported pain and moved.The mapping catheter was on the posterior wall of the left atrium between the two pulmonary veins, specifically closer to the inferior pulmonary vein, when the pain was reported.An echocardiogram was then performed which diagnosed a pericardial effusion.The effusion was drained and medication was administered to reverse the heparin the patient initially received.Then patient was then stabilized and the procedure was not continued.There were no patient symptoms.There were no performance issues with the abbott device.
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 ifu, vascular perforation is an inherent risk of any electrode placement.  .
Event or Problem Description
During an atrial fibrillation ablation procedure, a cardiac tamponade was diagnosed via echocardiogram.Initially when starting to map the left atrium of the patient, the patient reported pain and moved.The mapping catheter was on the posterior wall of the left atrium between the two pulmonary veins, specifically closer to the inferior pulmonary vein, when the pain was reported.An echocardiogram was then performed which diagnosed a pericardial effusion.The effusion was drained and medication was administered to reverse the heparin the patient initially received.Then patient was then stabilized and the procedure was not continued.There were no patient symptoms.There were no performance issues with the abbott device.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 13598866
• Report Number: 3008452825-2022-00068
• Device Sequence Number: 14917110
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160335
• 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
• Report Date (Section B): 02/25/2022

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: 02/28/2023
• Device Model Number: D-AVSE-DF10-F15
• Device Catalogue Number: D-AVSE-DF10-F15
• Device Lot Number: 8146625
• 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: 02/14/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 53 KG