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

Model Number RFP-265

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

Patient Problems Cardiac Arrest (1762); Death (1802); Hematoma (1884)

Event Type  Death  

Manufacturer Narrative

There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as baylis medical device were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.

Event Description

During a periodic review of published literature by the manufacturer, baylis medical devices were identified among several other manufacturers' devices as having been used in procedures with reported complications.There is no evidence to suggest the baylis medical devices caused or contributed to the reported complications.However, as the baylis devices were among the several devices used in the procedures, baylis medical has decided to submit this report.Article reference: boudjemline, y., sizarov, a., malekzadeh-milani, s., mirabile, c., lenoir, m., khraiche, d.,.Bonnet, d.(2017).Safety and feasibility of the transcatheter approach to create a reverse potts shunt in children with idiopathic pulmonary arterial hypertension.Can j cardiol, 33(9), 1188-1196.Doi:10.1016/j.Cjca.2017.06.004 as per this article: "intervascular bleeding was observed in 3 patients on rf perforation because of an increased distance between the dao and lpa, as noted on baseline angiography.Two patients (nos.3 and 5) demonstrated critically reduced lv systolic function resulting in cardiac arrest within 30 minutes after establishment of the potts shunt.The first patient had multiple events that could have contributed to hemodynamic instability and cardiac arrest.They included hemodynamic collapse after anesthetic induction requiring multiple resuscitations with inotropic support and cardioversion for atrial tachycardia and stent embolization and retrieval with potential severe bleeding through the vessel wall defects before the successful placement of the second covered stent.Interestingly, she also had a large atrial septal defect with a massive right to left shunt that did not protect her from lv unloading.Similarly, the second patient experienced cardiac arrest at anesthesia induction, requiring cardiopulmonary resuscitation followed by a persistently low cardiac output state before tps despite inotropic support.This patient also required multiple attempts at perforation, and the delivery sheath had to be exchanged before the successful crossing of the vascular walls.This consequently delayed the stent implantation and increased the potential for bleeding, which may have been greater than we estimated." separate mdr reports have been submitted for the devices mentioned in the article.The mfr report number for the protrack microcatheter is 9710452-2020-00008.

• 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: 9941306
• MDR Text Key: 187001187
• Report Number: 9710452-2020-00007
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RFP-265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2020
• 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): Death; Other