MAUDE Adverse Event Report: ABBOTT MEDICAL SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401430
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, after insertion into the patient, the catheter appearance looked wrong on fluoroscopy.The catheter was removed and was noted to be fractured at the distal end between the curve and the shaft.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 6f, quadripolar, jsn, supreme ep catheter was received for evaluation.The shaft of the catheter shaft was noted to be fracture at the gray/black shaft bond joint.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No nonconformances associated with the reported event were identified.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ABBOTT 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): ABBOTT 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: 23077672
• Report Number: 3008452825-2025-00460
• Device Sequence Number: 13196084
• Product Code: DRF
• UDI-Device Identifier: 05414734201285
• UDI-Public: (01)05414734201285(10)10856020(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894500
• 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): 11/05/2025

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: 401430
• Device Catalogue Number: 401430
• Device Lot Number: 10856020
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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