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 Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product's lot number could not be obtained; therefore, the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During a procedure, the catheter became entangled in the mitral valve and could not be freed.The catheter had to be surgically removed, and the mitral valve had to be replaced.The patient is stable.
Event or Problem Description
During a de novo af pvi procedure, the catheter became entangled in the mitral valve and could not be freed.The catheter had to be surgically removed, and the mitral valve had to be replaced.The patient was noted to have a slightly rotated anatomy and a very large left atrial appendage.The patient is stable.There were no alleged performance issues with the catheter.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The reported event of entanglement was confirmed.No devices were returned for investigation; however, seven images were received.The images were of the catheter on either the ensite screen or fluoroscopy and showed the catheter loop entangled with itself.One photo showed the loop of the catheter post-removal; the loop was bent and twisted in multiple locations.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 entanglement could not be conclusively determined.

• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21327534
• Report Number: 3008452825-2025-00054
• Device Sequence Number: 7914860
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 05/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-D10-V1525
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 02/11/2025; 04/16/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/06/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown