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

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

Patient Problems Tachycardia (2095); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440); Heart Block (4444)

Event Type  Injury  

Manufacturer Narrative

There is no suspected device failure.

Event Description

During a literature review, an article[1] was identified in which the nykanen rf wire was used in 31 radiofrequency pulmonary valve perforation procedures amongst other devices (baylis rf generator, judkins right catheter, 0.014-inch floppy wire, coronary balloons), 10 of the procedures resulted in procedural complications.Three patients experienced supraventricular tachycardia during the procedure, with two requiring adenosine and the other having spontaneous resolution of the condition.Two patients experienced complete heart block during the procedure, which returned sinus rhythm with steroid and atropine therapy.Arterial thrombosis occurred in three patients and recovered with heparin therapy over 24 hours.Cardiac perforation and tamponade occurred in 2 patients during the procedure who had urgent pericardiocentesis followed by accomplished transvenous pvp and balloon pulmonary valvuloplasty.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.[1] yoldas, t., orun, u.A., dogan, v., ozgur, s., kutsal, a., tak, s., & dilli, d.(2020).Transcatheter radiofrequency pulmonary valve perforation in newborns with pulmonary atresia/intact ventricular septum: echocardiographic predictors of biventricular circulation.Echocardiography.Doi:10.1111/echo.14811.

• Brand Name: NYKANEN RADIOFREQUENCY WIRE
• 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: 10649996
• MDR Text Key: 210500956
• Report Number: 9710452-2020-00029
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K010265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention