MAUDE Adverse Event Report: ST. JUDE MEDICAL SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401449
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, a break occurred in the catheter.The catheter was introduced via femoral venous way and placed in the coronary sinus without difficulty.During introduction of the second catheter, x-ray showed discontinuity of the catheter.Upon removal of the device, a separation was noted between the body of the catheter and the distal part, with exposure of the copper conductors noted.There were no patient consequences.The piece is retained by the hospital.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported fracture remains unknown.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 6f, quadripolar, crd, supreme ep catheter was received for evaluation.Visual inspection revealed the shaft of the catheter shaft was fractured at the gray/black shaft bond joint exposing internal wires.The appropriate personnel have been notified of this event and the issue will continue to be trended.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21874501
• Report Number: 3008452825-2025-00183
• Device Sequence Number: 20992853
• Product Code: DRF
• UDI-Device Identifier: 05414734201414
• UDI-Public: (01)05414734201414(10)10503162(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151622
• 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): 09/25/2025

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 Model Number: 401449
• Device Catalogue Number: 401449
• Device Lot Number: 10503162
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 09/18/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/16/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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