MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81207
Medical Device Problem Codes	Signal Artifact/Noise (1036); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, a displaced electrode was noted.While in the right atrium, there was no signal noted on the ep system.Upon inspection of the catheter, it was noted that the electrodes were not correctly arranged and the spacing was not correct.Another catheter was used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One duodecapolar, inquiry steerable diagnostic catheter was received for evaluation.Visual inspection revealed electrode rings 2-19 were found displaced and had migrated towards the distal tip.Electrodes 1 and 20 met specifications of acceptable resistance values.Electrodes 2-19 read as open circuits and were displaced.Electrodes 2-19 were displaced from their intended locations on the shaft.The conductor wires were fractured and detached from their respective electrode rings.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of displaced electrode rings and fractured conductor wire remains unknown.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17325694
• Report Number: 2030404-2023-00049
• Device Sequence Number: 5510173
• Product Code: DRF
• UDI-Device Identifier: 05414734303477
• UDI-Public: 05414734303477
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/11/2023

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 Expiration Date: 01/31/2026
• Device Model Number: IBI-81207
• Device Catalogue Number: IBI-81207
• Device Lot Number: 8900628
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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