MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F; Catheter, Electrode Recording, Or Probe, Electrode Recording

Model Number	IBI-87008
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial fibrillation ablation procedure in the anatomy construction stage, the catheter became trapped in the chordae tendineae of the mitral valve.The surgeon performed maneuvers in an attempt to loosen the catheter, however, fracture and detachment of the distal part of the catheter body occurred.Patient underwent cardiac surgery to remove the fragment.Patient stable according to attending physician.
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 incident could not be conclusively determined.

• Brand Name: INQUIRY AFOCUSII¿ (4 F DOUBLE LOOP) CATHETER 20 ELECTRODE, 7F
• 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 north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 18434834
• Report Number: 2030404-2023-00083
• Device Sequence Number: 7660587
• Product Code: DRF
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2026

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-87008
• Device Lot Number: 9079161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 04/17/2024; 08/28/2026
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 05/10/2024; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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: Required Intervention
• Patient Sex: Unknown