PowerWire Radiofrequency GuideWire Kit EWK35-250-12-6A-30-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447001072), received between Jan 3, 2020 and Jan 3, 2020 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE IN WHICH THE POWERWIRE RADIOFREQUENCY GUIDEWIRE KIT WAS USED, IT WAS SUSPECTED THAT A TAMPONADE OCCURRED. THE PHYSICIAN ATTEMPTED TO CROSS AN OCCLUDED SUPERIOR VENA CAVA (SVC) WITH THE POWERWIRE AND WAS SUCCESSFUL. FIFTEEN MINUTES LATER, WHILE INTRODUCING OTHER WIRES, SHEATHS AND A BALLOON INTO THE PATIENT, THE PATIENT'S STATUS DETERIORATED AND A CODE WAS CALLED. THE PHYSICIAN BELIEVED THAT A TAMPONADE OCCURRED. VARIOUS HEALTHCARE PROFESSIONALS WERE CALLED TO ASSIST WITH THE COMPLICATION. CHEST COMPRESSIONS WERE PERFORMED ON THE PATIENT. THE PATIENT REGAINED THEIR PULSE AND WAS REPORTED TO NOW BE DOING FINE. THERE IS NO EVIDENCE TO SUGGEST THAT A 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.

  Patient problems: Cardiac Tamponade

  MAUDE report 9548583 ↗