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-D10-F15
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/25/2021
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 clot could not be conclusively determined.
Event or Problem Description
During an atrial fibrillation ablation procedure, after conducting the transseptal puncture, the physician suspected there was a clot on the mapping catheter when using transesophageal echocardiography.The procedure was continued with only using the ablation catheter for mapping and ablation and the mapping catheter was not moved.A bolus of heparin was delivered and the procedure was able to be completed with no adverse consequences to the patient.Both the ablation and mapping catheter were removed using transesophageal echocardiography and no clots were observed.The physician suspected the clot was from the right atrium and went into the left atrium when the transseptal puncture was conducted.

• 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
• MDR Report Key: 11929162
• Report Number: 3008452825-2021-00311
• Device Sequence Number: 4345221
• Product Code: DRF
• UDI-Device Identifier: 05415067024800
• UDI-Public: 05415067024800
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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: 07/31/2022
• Device Model Number: D-AVSE-D10-F15
• Device Catalogue Number: D-AVSE-D10-F15
• Device Lot Number: 7837781
• 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: 05/25/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other