MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number	401575
Medical Device Problem Codes	Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)
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: 3008452825-2022-00407, 3008452825-2022-00408.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: d9, g3, h2, h3.One 6f, decapolar, medium sweep, livewire ep catheter was received for evaluation.Electrode 7 read as an open circuit.Electrode ring 7 was dissected to reveal that conductor wire 7 was fractured proximal to the weld joint, consistent with the open circuit detected and the reported noise and display issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, 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: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14306228
• Report Number: 2182269-2022-00026
• Device Sequence Number: 11960698
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K022380
• 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: 11/30/2024
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 8185167
• 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: 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: 12/13/2021
• 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: SUPREME¿ EP CATHETER; SUPREME¿ EP CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown