MAUDE Adverse Event Report: ST. JUDE MEDICAL RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, EL; ELECTRODE RECORDING CATHETER

Model Number	401226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/26/2023
Type of Reportable Event	Death
Event or Problem Description
During an ventricular tachycardia ablation procedure, a pericardial effusion occurred which required a pericardiocentesis.A transseptal puncture was performed, but no effusion was seen on echography during or after the transseptal puncture.During rf lesions on the septum/anterior left ventricle, the patient was stable.The patient became hypotensive at the end of the procedure, when catheters were removed from the right ventricle.An echography revealed a pericardial effusion and around 880 ml of blood was drained from the pericardium without blood re-injection.The procedure was then completed.There were no alleged performance issues with any abbott devices.It is alleged that the effusion was due to the catheter in the right ventricle because the patient became hypotensive when the catheter was removed and because the color of the blood removed with the drainage was blood poor in oxygen.The patient died after this procedure due to heart failure, specifically ventricular fibrillation.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a ventricular tachycardia ablation procedure, a pericardial effusion occurred which required a pericardiocentesis.A transseptal puncture was performed, but no effusion was seen on echography during or after the transseptal puncture.During rf lesions on the septum/anterior left ventricle, the patient was stable.The patient became hypotensive at the end of the procedure, when catheters were removed from the right ventricle.An echography revealed a pericardial effusion at the right ventricular apex and around 880 ml of blood was drained from the pericardium without blood re-injection.The procedure was then completed.There were no alleged performance issues with any abbott devices.It is alleged that the effusion was due to the response electrophysiology quadripolar catheter in the right ventricle because the patient became hypotensive when the catheter was removed and because the color of the blood removed with the drainage was blood poor in oxygen.The procedure was completed.There were no performance issues with any abbott devices.It was noted that the patient died 1-2 days after this procedure due to heart failure, specifically ventricular fibrillation.The physician stated that the patient was fragile before the procedure and had a low lvef around 30%.An autopsy confirmed that the patient expired because of vf, and the death did not occur because of the cardiac perforation.There is no further information available regarding the autopsy results.

• Brand Name: RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, EL
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17160048
• Report Number: 3008452825-2023-00263
• Device Sequence Number: 12160092
• Product Code: DRF
• UDI-Device Identifier: 05414734200554
• UDI-Public: 05414734200554
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K894500
• 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): 08/11/2023

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 Expiration Date: 09/30/2025
• Device Model Number: 401226
• Device Catalogue Number: 401226
• Device Lot Number: 8718862
• Was Device Available for Evaluation?: No
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death; Other
• Patient Sex: Unknown