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

Model Number	IBI-81918
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the premature ventricular contraction procedure, when attempting to locate an electrode in the coronary sinus, it was noted that damage was found on the distal end of the electrode.A crack was found on the mobile electrode deflection point.The catheter was exchanged and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One decapolar, inquiry luma-cath diagnostic catheter was received for evaluation.The catheter shaft was bent and the shaft material was twisted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend and twisted shaft material remains unknown.

• Brand Name: INQUIRY¿ LUMA-CATH¿STEERABLE 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: 15476504
• Report Number: 2030404-2022-00060
• Device Sequence Number: 6020268
• Product Code: DRF
• UDI-Device Identifier: 05414734306201
• UDI-Public: 05414734306201
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K991878
• 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): 10/26/2022

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: 05/31/2023
• Device Model Number: IBI-81918
• Device Catalogue Number: IBI-81918
• Device Lot Number: 7544924
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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