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-D10-V1525

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 02/27/2024

Event Type  Injury  

Event Description

Related manufacturing reference: 3008452825-2024-00135.During the pulmonary vein isolation procedure, a cardiac tamponade occurred which required a pericardiocentesis to stabilize the patient.The procedure was being performed with ensite x system in voxel mode.Two catheters were in the left atrium for mapping and ablation.During mapping, the tamponade occurred, it was unclear the cause but most probably the left atrial appendage was perforated.A pericardiocentesis was performed, the patient stabilized and was admitted to the icu for observation.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 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, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: ADVISOR¿ VL, SENSOR ENABLED¿ CIRCULAR MAPPING CATHETER
• Type of Device: 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: 18881842
• MDR Text Key: 337406134
• Report Number: 3008452825-2024-00134
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067027252
• UDI-Public: 05415067027252
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K192037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: D-AVSE-D10-V1525
• Device Lot Number: 8857958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Patient Outcome(s): Life Threatening; Required Intervention