MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401451
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: 2182269-2022-00026 and 3008452825-2022-00407.During a supraventricular ablation procedure with wolfe parkinson white syndrome, a pericardial effusion was noted in the coronary sinus.During the procedure, electrode 7-8 of the steerable catheter showed noise and stretching on the system screen and the physicians involved stated high impedance was noted.The signals of cs 7-8 were hidden from both the ensite precision and the ep recording system to continue the procedure.Access the coronary sinus (cs) was attempted with the steerable catheter, and subsequently with the help of the sl3 sheath.A non abbott guidewire was then used to guide the cs catheter.After the catheters were in place, the study was performed.The patient then became restless and stats dropped to approximately 70+.An echo was then performed which revealed an effusion.However, the procedure was abandoned midway through the study as the patient experienced a pericardial effusion which was confirmed via echocardiogram.A pericardiocentesis was performed which stabilized the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 one image and one video were received for evaluation that appeared to show noise and a display issue during the procedure.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 pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); 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: 14306285
• Report Number: 3008452825-2022-00408
• Device Sequence Number: 5026582
• Product Code: DRF
• UDI-Device Identifier: 05414734201438
• UDI-Public: 05414734201438
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K002976
• 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): 06/07/2022

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: 10/31/2024
• Device Model Number: 401451
• Device Catalogue Number: 401451
• Device Lot Number: 8231731
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIVEWIRE¿ EP CATHETER; SUPREME¿ EP CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown