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	Cardiac Perforation (2513)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.A review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.
Event or Problem Description
During a pulmonary atresia procedure where the nykanen radiofrequency wire kit was used, a cardiac perforation was confirmed after replacing the nykanen device with a guidewire and a microcatheter.The perforation was treated with surgery.There is no evidence to suggest the baylis medical devices caused or contributed to the reported complications.However, as baylis devices were among the several devices used in the procedures, 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
• MDR Report Key: 10862934
• Report Number: 9710452-2020-00034
• Device Sequence Number: 3766261
• Product Code: GEI
• UDI-Device Identifier: 00685447000976
• UDI-Public: (01)00685447000976(17)220328(10)RKFA290618
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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: 03/28/2022
• Device Model Number: RFK-265
• Device Lot Number: RKFA290618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention