MAUDE Adverse Event Report: ABBOTT MEDICAL 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the distal electrode of the mapping catheter detached.When attempting to withdraw the catheter through the sheath, it became entrapped and resistance was felt.The catheter signal was poor and when the catheter was removed it was noted that the distal electrode has become detached.The catheter was exchanged and the procedure was completed.It is unknown whether the detached electrode was successfully retrieved or remains within the patient.The electrode fragment was not visualized externally.Fluoroscopic imaging was reviewed in an attempt to locate the electrode fragment, but definitive confirmation of its presence or absence in the patient could not be obtained at the time of the procedure.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.There were no devices were received for analysis, however the returned photo appeared to show the catheter with a fractured and detached tip electrode.The internal components of the catheter were exposed.Visual inspection was based solely upon a review of the photograph provided.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported detached distal electrode remains unknown.

• 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): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ABBOTT MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22216700
• Report Number: 2030404-2025-00022
• Device Sequence Number: 12799077
• Product Code: DRF
• UDI-Device Identifier: 05414734309929
• UDI-Public: (01)05414734309929(10)10145800(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101623
• 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): 08/14/2025

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 Model Number: IBI-87008
• Device Catalogue Number: IBI-87008
• Device Lot Number: 10145800
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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
• Patient Sex: Unknown