MAUDE Adverse Event Report: ABBOTT MEDICAL RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401223
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrioventricular nodal reentrant tachycardia procedure, the diagnostic catheter fractured while in the right atrium.It was not maneuvering properly and so the catheter was removed.The catheter was bent and separated at the boundary between the black and grey portion of the catheter where the shaft and distal electrode transition.The catheter was replaced and the procedure was completed successfully with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h3, h4, h11.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 5f, quadripolar, jsn, response ep catheter was received for evaluation.The shaft of the catheter shaft was noted to be fracture at the gray/black shaft bond joint.Additionally, a foreign material was found embedded in the catheter shaft material at the fractured bond joint.The reported issue will continue to be trended.

• Brand Name: RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL
• 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: 22216556
• Report Number: 3008452825-2025-00282
• Device Sequence Number: 8659412
• Product Code: DRF
• UDI-Device Identifier: 05414734200523
• UDI-Public: (01)05414734200523(10)10622863(17)271031
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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: 401223
• Device Catalogue Number: 401223
• Device Lot Number: 10622863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 08/04/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/22/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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