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

Model Number RFK-265

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

Physician had a jr2 catheter (containing coronary wire and protrack microcathether) positioned under the atretic pulmonary valve; when the coronary wire was exchanged for nykanen.The nykanen wire was straightening out their jr2 catheter, and they no longer had a good positioning under the valve.Physician opted for stiff back end of guidewire and mechanically crossed through the valve because they could not get good positioning when using the nykanen wire.While there was no adverse event related to the use of the baylis medical device, baylis medical technologies considers a device malfunction leading to a surgical delay of greater than 15 minutes to be an fda reportable event.

Manufacturer Narrative

While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the procedural delay.

• 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 H4T1A 1; CA H4T1A1
• 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: 15810261
• MDR Text Key: 305492350
• Report Number: 9710452-2022-00049
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFK-265
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other