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

Model Number	IBI-81107
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, difficulties were noted when inserting the catheter into the patient and upon removal, it was noted to be fractured.The catheter was exchanged, and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.Multiple kinks were noted along the catheter shaft.No other visual anomalies were noted.Microscopic inspection of the tip and shaft electrodes revealed no anomalies.Microscopic inspection of the catheter shaft revealed no fractures or other anomalies.The catheter shaft outer diameter measurement was consistent with specifications.The returned catheter was inserted through the entire length of an introducer from current abbott inventory with no resistance noted.No fractures were observed along the catheter shaft.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the reported insertion difficulty and fracture remains unknown.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18209001
• Report Number: 3008452825-2023-00542
• Device Sequence Number: 7467285
• Product Code: DRF
• UDI-Device Identifier: 05414734303002
• UDI-Public: (01)05414734303002(10)9241438(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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
• Device Expiration Date: 08/31/2026
• Device Model Number: IBI-81107
• Device Catalogue Number: IBI-81107
• Device Lot Number: 9241438
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 07/09/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/19/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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
• Patient Sex: Unknown