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

Model Number	D-AVSE-D20-V1525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/01/2021
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 effusion remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
Related manufacturing ref: 3008452825-2021-00185, 34138-2021-00209, 3008452825-2021-00186, 3008452825-2021-00187, 2184149-2021-00101.Following a pulmonary vein isolation procedure in ensite x voxel mode, a pericardial effusion was detected posterior right ventricle.During the procedure it was difficult to maneuver the sheaths towards the vena cava.However, the left pulmonary veins were successfully ablated.The decision was then made to stop the procedure due to the maneuvering difficulties.The patient was in conscious sedation and had a stable blood pressure.At the end of the procedure, a pericardial effusion was detected with no intervention required.The blood pressure stabilized, the patient recovered and was discharged.Per the physician, the reported oversized shell involving the ensite x may have contributed to the effusion.

• Brand Name: ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11582308
• Report Number: 3005334138-2021-00208
• Device Sequence Number: 19879460
• Product Code: DRF
• UDI-Device Identifier: 05415067027269
• UDI-Public: 05415067027269
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K192037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 10/31/2023
• Device Model Number: D-AVSE-D20-V1525
• Device Catalogue Number: D
• Device Lot Number: 7751928
• 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: 03/15/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS NXT INTRODUCER; ENSITE¿ X EP SYSTEM; INQUIRY STEERABLE CATHETER; SWARTZ BRAIDED INTRODUCER, SL0; TACTICATH ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Other