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

Model Number	IBI-81594
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial tachycardia procedure, the inquiry afocus ii catheter was pushed abnormally and the sheath was stuck causing the ring electrode to separate from the shaft when it the inquiry afocus ii catheter was pulled out.The inquiry afocus ii catheter was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.The spiral loop and distal shaft had been fractured and detached from the proximal shaft.Additionally, electrode 5 had been cracked, bent, and displaced distally due to the aforementioned damage.The outer diameter of the catheter shaft met specifications.Information received indicates the catheter was ¿pushed abnormally¿.The inquiry afocus ii instructions for use (ifu) states, ¿excessive bending or kinking of the catheter may cause damage to the catheter.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the catheter damage and reported event of catheter stuck is consistent with not following the instructions for use.

• Brand Name: INQUIRY¿ AFOCUS LL¿ DIAGNOSTIC CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17319184
• Report Number: 2030404-2023-00048
• Device Sequence Number: 12285974
• 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,Followup
• Report Date (Section B): 09/12/2023

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: 10/31/2025
• Device Model Number: IBI-81594
• Device Catalogue Number: IBI-81594
• Device Lot Number: 8741113
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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