MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NYKANEN RADIOFREQUENCY WIRE KIT; RF PERFORATION PROBE

Model Number	RFK-265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A dhr review has been completed for the lot in question and all the devices in the lot met relevant requirements prior to release.
Event or Problem Description
A case of right ventricular outflow tract (rvot) perforation was reported in a procedure where the nykanen rf wire kit was used on a patient with pulmonary atresia with intact ventricular septum (pa/ivs).The nykanen rf wire was delivered via right femoral access to the target puncture site using a 4fr judkins curve angiographic catheter and a masters microcatheter (asahi intech).The position of the nykanen rf wire was confirmed on fluoroscopy bilaterally.Rf energy was delivered and resulted in perforation of rvot.The procedure was aborted, and open chest surgery was performed where it was confirmed the tip of the rf wire was located inside the pericardium.The perforation did not lead to cardiac tamponade, with only slight changes in the patient's vital signs.After repair of the perforation site and removal of the rf wire, the patient showed minimal bleeding.The patient was moved to icu where the blood pressure dropped and the patient had to undergo extracorporeal membrane oxygenation.The patient remained in icu as of (b)(6) 2022.The physician indicated there were no notable characteristics associated with the patient's anatomy.The physician did not encounter challenge determining the puncture site.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: NYKANEN RADIOFREQUENCY WIRE KIT
• Common Device Name: RF PERFORATION PROBE
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 14620644
• Report Number: 9710452-2022-00048
• Device Sequence Number: 5140684
• Product Code: GEI
• UDI-Device Identifier: 00685447000976
• UDI-Public: (01)00685447000976(17)240701(10)RKFA310521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: 07/01/2024
• Device Model Number: RFK-265
• Device Lot Number: RKFA310521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown