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

Model Number	IBI-81104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of a ventricular tachycardia ablation, there was a pericardial effusion in the right ventricle.It is alleged that the cause of the perforation was the inquiry steerable diagnostic catheter.Transseptal puncture was performed and then mapping of the ventricular tachycardia was completed in the left ventricle.Once ablation was completed another ventricular tachycardia was then mapped.It was attempted to stimulate the right ventricle and push the inquiry steerable diagnostic catheter at the apex, but there was not a good localization.The inquiry steerable diagnostic catheter was repositioned and then it was noted on the screen of the x-ray that the inquiry steerable diagnostic catheter was out of the shadow of the heart.The patient was experiencing painful, tachycardia, and low blood pressure.The pericardial effusion was confirmed by an echocardiogram at the apex of the right ventricle.A pericardiocentesis was performed, 2 units of packed red blood cells, inotropes medications, and protamine was administered to stabilize the patient.There were no alleged performance issues with the inquiry steerable diagnostic catheter.
Additional Manufacturer Narrative
One quadripolar, inquiry steerable diagnostic catheter was received for evaluation.Electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pericardial effusion remains unknown as it could not be confirmed.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 19003684
• Report Number: 2030404-2024-00025
• Device Sequence Number: 8501913
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• 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
• Report Date (Section B): 06/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBI-81104
• Device Lot Number: 10163447
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown