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

Model Number IBI-81104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 03/21/2024

Event Type  Injury  

Event 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.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Type of Device: 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
• MDR Text Key: 338904413
• Report Number: 2030404-2024-00025
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734302975
• UDI-Public: 05414734302975
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

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
• Device Operator: Health Professional
• Device Model Number: IBI-81104
• Device Lot Number: 10163447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other