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

Model Number	IBI-81403
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, it was noted that the curvature of the catheter was unusual resulting in a delay.The catheter was exchanged however the same issue occurred with the new catheter.The catheter was exchanged again to resolve the issue.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Corrected information: h6.Corrected the health impact code to 4604 - delay to treatment/ therapy.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One quadripolar, inquiry steerable diagnostic catheter was received for evaluation.The reported deflection issue was confirmed.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to kink in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kink remains unknown.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC 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: 23825053
• Report Number: 3008452825-2025-00637
• Device Sequence Number: 8954647
• Product Code: DRF
• UDI-Device Identifier: 05414734304139
• UDI-Public: (01)05414734304139(10)10987759(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/17/2026

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-81403
• Device Catalogue Number: IBI-81403
• Device Lot Number: 10987759
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 02/17/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER.
• Patient Sex: Unknown