MAUDE Adverse Event Report: ABBOTT MEDICAL INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81402
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 pericardial effusion remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
During a supraventricular tachycardia (svt) ablation, a pericardial effusion occurred with no intervention needed.Cardiac motion was restricted on fluoroscopy and the patient experienced minor chest pain.While using the ice catheter, an effusion was noted; tee confirmed a 0.5cm effusion.No intervention was required; the procedure was stopped and the patient was observed overnight.It is suspected that the perforation was due to difficult rv placement.There were no performance issues with any abbott devices.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER
• 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: 22283747
• Report Number: 3008452825-2025-00287
• Device Sequence Number: 8467214
• Product Code: DRF
• UDI-Device Identifier: 05414734304122
• UDI-Public: (01)05414734304122(10)10526549(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
• Report Date (Section B): 06/18/2025

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 Model Number: IBI-81402
• Device Catalogue Number: IBI-81402
• Device Lot Number: 10526549
• 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: 06/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown