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

Model Number	IBI-81102
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, it was noted that the proximal electrodes 7-8 and 9-10 had no physical spacing.No anomalies were noted prior to insertion, and the catheter electrode spacing was displaying correctly on the mapping system.There were no difficulties removing or inserting the catheter through the introducer.The size used was 7f.The device was not replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one decapolar, inquiry steerable diagnostic catheter was received for evaluation.Electrodes 7-10 were displaced with no physical spacing between them and they migrated towards the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the displaced electrodes 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; 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): ST. JUDE 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16806846
• Report Number: 3008452825-2023-00174
• Device Sequence Number: 16910225
• Product Code: DRF
• UDI-Device Identifier: 05414734302968
• UDI-Public: 05414734302968
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 08/31/2025
• Device Model Number: IBI-81102
• Device Catalogue Number: IBI-81102
• Device Lot Number: 8646865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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