MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81102
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contractions (pvc) procedure in the right ventricle (rv), noise issues with the ep catheter resulted in a procedural delay.The cs catheter egms were noisy and then improved some.The cs catheter was left in the ra/svc junction.Multiple pvcs were observed so the mapping catheter was inserted into the right atrium (ra) to prepare for mapping.Egms on the mapping catheter were noisy as well.All connections were checked.The mapping catheter cable was replaced but the issue persisted.The claris and ensite were turned off and on again but the noise issue continued.All ecg connections were checked and the rl and ra patches were replaced and changed to claris ecg only but the issue was not resolved.Returned to ensite ecg and replaced the mapping catheter but still no improvement.The physician moved the mapping catheter into the right rv and the noise issue was resolved.After ablation was completed, the physician pulled the mapping catheter back into the ra and the noise returned.On fluoroscopy, the mapping catheter was adjacent to the cs catheter so it is thought that maybe the noise issue is related to the cs catheter.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One decapolar, inquiry steerable diagnostic catheter was received for evaluation.Electrode 8 read as open circuit.Dissection revealed conductor wire 8 had been fractured proximal to the weld joint, consistent with the open circuit detected and the reported noise issue.Electrodes 1-7 and 9-10 met specifications of acceptable resistance values.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of fractured conductor wire remains unknown.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21689331
• Report Number: 2030404-2025-00014
• Device Sequence Number: 8774572
• Product Code: DRF
• UDI-Device Identifier: 05414734302968
• UDI-Public: (01)05414734302968(10)10514018(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K961924
• 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): 04/23/2025

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: IBI-81102
• Device Catalogue Number: IBI-81102
• Device Lot Number: 10514018
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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