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

Model Number	IBI-81104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762)
Date of Event	02/17/2025
Type of Reportable Event	Death
Event or Problem Description
During an atrial flutter procedure, the patient became bradycardic, went into cardiac arrest, and expired.The procedure began by positioning the inquiry catheter in the coronary sinus and using a non-abbott intracardiac echo probe to map the right atrium.The map and geometry were collected with a non-abbott circular catheter.The typical atrial flutter ablation was performed with a non-abbott 8mm rf ablation catheter.After mapping and ablation in the right atrium were completed, the non-abbott circular catheter was moved to the left atrium via transseptal puncture using swartz and agilis sheaths and a brk needle.Geometry of the left atrium and a voltage map were collected and showed an electrical signal in the pulmonary veins.Isolation of the pulmonary veins began with a non-abbott (farapulse, boston scientific) catheter and non-abbott (boston scientific) equipment and technical support.Immediately after ablation of the pulmonary veins, a new map of the left atrium was collected using the non-abbott circular catheter to check whether the veins were isolated.At that moment, after the geometry collection began on the posterior wall of the left atrium, the patient became bradycardic and went into cardiac arrest.The team performed resuscitation maneuvers, but after a period of attempts, the patient died.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported cardiac arrest and death could not be conclusively determined.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21528909
• Report Number: 3008452825-2025-00071
• Device Sequence Number: 18237291
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: (01)05414734302975(10)9077648(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/20/2025

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 Expiration Date: 05/31/2026
• Device Model Number: IBI-81104
• Device Catalogue Number: IBI-81104
• Device Lot Number: 9077648
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female