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

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Event 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.

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
• 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: 16122891
• MDR Text Key: 307670547
• Report Number: 3008452825-2022-00742
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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