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-DF10-F20
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the advisor hd grid catheter became entangled with the advisor fl in the left atrium and the catheters could not be removed.When attempting to remove the catheters using a snare, a atrial septal defect developed upon exiting the right atrium and the catheters were successfully removed using an ablation catheter.Pulmonary vein isolation was performed, and the procedure was completed which took approximately 2 hours longer than usual.The catheters were replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 10 pole, bi-directional, curve d-f, sensor enabled, advisor vl circular mapping catheter was received for evaluation.Three images were also submitted for evaluation.The shaft material was compressed between electrode 4 and 6, electrode 6 was displaced and the catheter loop was twisted proximal to electrode 10.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the entanglement and damage remains 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: 17324687
• Report Number: 3008452825-2023-00309
• Device Sequence Number: 6290551
• Product Code: DRF
• UDI-Device Identifier: 05415067025968
• UDI-Public: 05415067025968
• 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): 08/31/2023

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: 05/31/2024
• Device Model Number: D-AVSE-DF10-F20
• Device Catalogue Number: D-AVSE-DF10-F20
• Device Lot Number: 8791529
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown