EnSite™ ENSITE-PRSBACK-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067033291), received between Oct 21, 2022 and Oct 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 16, 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.

• InjuryOct 21, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  RELATED MANUFACTURING REF: 2184149-2022-00254. DURING THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL PERFORATION OCCURRED AFTER AN ISSUE WITH THE PRS-P SENSORS CHANGING POSITIONS DUE TO PATIENT COUGHING AND BODY MOVEMENT WHILE MAPPING IN THE LEFT ATRIUM. DUE TO THE CHANGE IN POSITION OF THE SENSORS THE SYSTEM COULD NOT COLLECT ANY INFORMATION SUCH AS GEOMETRY. THE SENSORS ON THE PATIENT'S BACK WERE THEN FIXED WITH ADHESIVE, BUT AFTER THIS THE PATIENT BECAME HYPOTENSIVE AND A PERFORATION WAS FOUND IN THE LEFT ATRIUM VIA AN ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE WHEN THE CASE WAS CANCELLED. THE PHYSICIAN ALLEGES THE ISSUE WAS DUE TO THE BAD PERFORMANCE OF THE SYSTEM.

  Patient problems: Cardiac Perforation

  MAUDE report 15651259 ↗