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-F20
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3008452825-2023-00167.During an atrial tachycardia procedure, a communication issue occurred with the advisor hd grid catheter resulting in a delay to the procedure.The advisor hd grid catheter was inserted into the right atrium and mapping was performed.Then the advisor fl catheter was inserted into the left atrium and the mapping catheter of the ensite x setting was set to the advisor fl.The reference (cs) could not be collected, the mapping could not be performed with the advisor fl catheter while the electric potentials was not displayed.The electric potentials of the advisor fl catheter were displayed on the recording system.The catheter and the cable were re-connected, and re-set to the catheter set up screen of the ensite x, the dws was re-started, and the advisor fl catheter was replaced with a second one, but with no resolution.The left atrium was mapped with the advisor hd grid catheter.The procedure was completed and there were no adverse consequences to the patient.The hospital discarded only second catheter.
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 communication issue and subsequent delay remain unknown.

• 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: 16766377
• Report Number: 3008452825-2023-00168
• Device Sequence Number: 19642685
• Product Code: DRF
• UDI-Device Identifier: 05415067024817
• UDI-Public: 05415067024817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: D-AVSE-D10-F20
• Device Catalogue Number: D-AVSE-D10-F20
• Device Lot Number: 8670644
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SE
• Patient Sex: Unknown