Inquiry™ IBI-81945Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734306348), received between Feb 28, 2019 and Feb 28, 2019 — 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.

• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RIGHT ATRIAL FLUTTER PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHEN ATTEMPTING TO PLACE THE CORONARY SINUS CATHETER, THE DEVICE WOULD CANNULATE THE MIDDLE CARDIAC VEIN AND WOULD CONTINUALLY LOSE CONTACT. THE DEVICE WAS REPLACED TO A NON-ABBOTT CORONARY SINUS CATHETER, WHICH ALSO HAD DIFFICULTY BEING PLACED. AFTER NEARLY 40 MINUTES OF MANIPULATION, THE NON-ABBOTT CATHETER WAS ABLE TO BE PLACED IN THE CORONARY SINUS. THE PROCEDURE WAS CONTINUED AND BIDIRECTIONAL BLOCK WAS SUCCESSFULLY ACHIEVED. WHEN MANIPULATING THE ICE CATHETER, A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE USER BELIEVED THE PERFORATION WAS DUE TO THE CORONARY SINUS CATHETERS.

  Patient problems: Cardiac Perforation

  MAUDE report 8377908 ↗