MAUDE Adverse Event Report: ABBOTT MEDICAL SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD-2¿ CURVE, E; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401860
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrioventricular nodal reentrant tachycardia procedure, the catheter became tangled around itself when going up the iliac vein.It was attempted to untangle it but support from an interventional surgeon was required.When attempting to remove the catheter, it broke and the knot that had formed was stuck in the vein.A vascular surgeon was then called to remove the knot that remained.The knot was removed with ease after the initial incision was cut a little larger than before.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.The reported event of material separation and removal difficulty could not be confirmed.Two images were submitted for evaluation to product performance engineering; no product was received.The images returned shows the distal end of the catheter separated from the proximal shaft and knotted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured and detached shaft remains unknown.Based on the information received, the cause of the reported removal difficulty could not be conclusively determined.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD-2¿ CURVE, E
• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23405777
• Report Number: 3008452825-2025-00511
• Device Sequence Number: 20068657
• Product Code: DRF
• UDI-Device Identifier: 05414734201513
• UDI-Public: (01)05414734201513(10)10877479(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 401860
• Device Catalogue Number: 401860
• Device Lot Number: 10877479
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown