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

Model Number	IBI-81594
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of burn damage on the shaft of the catheter noted during analysis.
Additional Manufacturer Narrative
One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.Burn damage on the catheter shaft was noted at the spiral loop/shaft transition.No other visual anomalies were noted.The catheter did not deflect in the correct shape and did not meet specifications per curve due to the damage on the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage remains unknown.

• Brand Name: INQUIRY¿ AFOCUS LL¿ DIAGNOSTIC CATHETER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16627986
• Report Number: 2030404-2023-00018
• Device Sequence Number: 17257581
• Product Code: DRF
• UDI-Device Identifier: 05414734305006
• UDI-Public: 05414734305006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010471
• 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
• Report Date (Section B): 03/28/2023

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: 02/28/2025
• Device Model Number: IBI-81594
• Device Catalogue Number: IBI-81594
• Device Lot Number: 8392377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• 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: 03/16/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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