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-DF20-V1525
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the paroxysmal atrial fibrillation procedure using the advisor¿ vl, sensor enabled¿ circular mapping catheter, it was noted that it became entangled with the chordae tendineae.The catheter was inserted into the left atrium, and the catheter inserted into the left ventricle.When the geometry of the left atrium was being created, it was noted the catheter was entangled with the chordae tendineae, and it could not come out.The catheter was rotated, but it was still hard to remove, so the sheath was removed.No damage was seen on the catheter, but it was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 22 pole, bi-directional, curve d-f, sensor enabled, advisor vl circular mapping catheter was received for evaluation.The catheter loop was stretched and bent.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported removal difficulty and entanglement remains unknown.

• 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; 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: 16122891
• Report Number: 3008452825-2022-00742
• Device Sequence Number: 20443377
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: 02/28/2025
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-DF20-V1525
• Device Lot Number: 8399252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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
• Patient Sex: Unknown