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

Model Number RFK-265

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 02/22/2022

Event Type  Injury  

Event 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 and patent ductus arteriosus.The rvot was highly angulated.The nykanen rf wire was delivered to the target puncture site using a 4fr judkins right catheter.The inadvertent perforation occurred when the physician was attempting to puncture the pulmonary artery.The procedure was aborted and extracorporeal membrane oxygenation was employed.Cardiac function showed improvement afterwards.Central-shunt surgery was planned for a later date.The physician indicated the guiding catheter was not flexible enough for the angulated rvot.There is no evidence to suggest that baylis medical device caused or contributed to the reported incident.However, as a baylis medical device was reported to be among the devices use in the procedure, baylis medical has decided to submit this report.

Manufacturer Narrative

There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident and there is no suspected device malfunction.However, as the baylis medical devices were 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.

• Brand Name: NYKANEN RADIOFREQUENCY WIRE KIT
• Type of Device: 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: 13901257
• MDR Text Key: 287894205
• Report Number: 9710452-2022-00016
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 90685447000979
• UDI-Public: (01)90685447000979(17)231120(30)05(10)RKFA111119
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K010265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: RFK-265
• Device Lot Number: RKFA111119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention