Nykanen Radiofrequency Wire Kit RFK-265Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00685447000976), received between Nov 18, 2020 and Jun 7, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 WITH INTACT VENTRICULAR SEPTUM (PA/IVS). THE NYKANEN RF WIRE WAS DELIVERED VIA RIGHT FEMORAL ACCESS TO THE TARGET PUNCTURE SITE USING A 4FR JUDKINS CURVE ANGIOGRAPHIC CATHETER AND A MASTERS MICROCATHETER (ASAHI INTECH). THE POSITION OF THE NYKANEN RF WIRE WAS CONFIRMED ON FLUOROSCOPY BILATERALLY. RF ENERGY WAS DELIVERED AND RESULTED IN PERFORATION OF RVOT. THE PROCEDURE WAS ABORTED, AND OPEN CHEST SURGERY WAS PERFORMED WHERE IT WAS CONFIRMED THE TIP OF THE RF WIRE WAS LOCATED INSIDE THE PERICARDIUM. THE PERFORATION DID NOT LEAD TO CARDIAC TAMPONADE, WITH ONLY SLIGHT CHANGES IN THE PATIENT'S VITAL SIGNS. AFTER REPAIR OF THE PERFORATION SITE AND REMOVAL OF THE RF WIRE, THE PATIENT SHOWED MINIMAL BLEEDING. THE PATIENT WAS MOVED TO ICU WHERE THE BLOOD PRESSURE DROPPED AND THE PATIENT HAD TO UNDERGO EXTRACORPOREAL MEMBRANE OXYGENATION. THE PATIENT REMAINED IN ICU AS OF (B)(6) 2022. THE PHYSICIAN INDICATED THERE WERE NO NOTABLE CHARACTERISTICS ASSOCIATED WITH THE PATIENT'S ANATOMY. THE PHYSICIAN DID NOT ENCOUNTER CHALLENGE DET

  Patient problems: Perforation

  MAUDE report 14620644 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Cardiac Perforation

  MAUDE report 10862934 ↗