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

Model Number	IBI-81102
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a catheter used in the patient past the expiration date.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11 one decapolar, inquiry steerable diagnostic catheter was received for evaluation.The device was returned for a deflection issue and device damage.The reported deflection issue could not be confirmed.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications.The reported device damage was confirmed; the catheter shaft was found to be bent proximal to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deflection issue remains unknown.
Event or Problem Description
This report is to advise of a catheter used in the patient past the expiration date.
Additional Manufacturer Narrative
Corrected information: h2, h3.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F
• 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: 22774590
• Report Number: 3008452825-2025-00394
• Device Sequence Number: 9341773
• Product Code: DRF
• UDI-Device Identifier: 05414734302968
• UDI-Public: (01)05414734302968(10)8552613(17)250630
• 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,Followup,Followup
• Report Date (Section B): 09/19/2025

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 Expiration Date: 06/30/2025
• Device Model Number: IBI-81102
• Device Catalogue Number: IBI-81102
• Device Lot Number: 8552613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 09/19/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/19/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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