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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: (b)(4).During a premature ventricular contraction ablation procedure, an effusion occurred.A coronary sinus catheter was placed and then an ablation catheter was used to map the right ventricular outflow tract (rv/rvot).A map of the chamber was done up and past the pulmonary valve/pulmonary artery.The ablation catheter was difficult to keep stable, so a sheath was placed to further map the right outflow tract chamber and an area was found in lower outflow tract tricuspid valve.Four lesions were made in that area and was still inducible and the patient became hypotensive.A second attempt to place an ice catheter was done to assist with navigation of the catheters.The first attempt was abandoned as there was tortuosity of the vein, however this time a longer vascular sheath was user and the ice catheter was successfully placed in right atrium where an effusion was noted.A pericardiocentesis and transfusion were performed.A code was called to resuscitate the patient as there were several episodes of ventricular fibrillation requiring defibrillation and the patient was transferred to surgery for an open-heart pericardial window.The patient was extubated and is in stable condition.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: g4, h2, h3, h6.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.

• 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
• MDR Report Key: 10667553
• Report Number: 2182269-2020-00090
• Device Sequence Number: 19809136
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 06/30/2023
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 7533007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS NXT INTRODUCER; FLEXABILITY ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 79