Inquiry™ IBI-81659Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734305150), received between Jun 25, 2018 and Mar 19, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERFORATION OCCURRED AT THE LEFT ATRIAL APPENDAGE. THE EVENT WAS NOTED DURING THE INITIAL MAPPING PHASE OF THE LEFT ATRIUM, AFTER A DIFFICULT TRANSSEPTAL PUNCTURE ON A FLOPPY FOSSA OVALIS. THE PERFORATION LED TO A IMMEDIATE BLOOD LOSS AND THE ISSUE WAS RESOLVED BY PERFORMING A STERNOTOMY AND STITCHING THE APPENDAGE HOLE. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 13826407 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR NUMBER: 3005334138-2021-00070. DURING AN ATRIAL FIBRILLATION CRYOABLATION PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THE PATIENT HAD UNUSUAL CARDIAC ANATOMY. TWO DIFFERENT TRANSSEPTAL NEEDLES WERE USED TO MAKE MULTIPLE ATTEMPTS TO CROSS THE ATRIAL SEPTUM. AFTER WHAT WAS BELIEVED TO BE A SUCCESSFUL PUNCTURE, THE INTRODUCER WAS ADVANCED AND THE DIAGNOSTIC CATHETER WAS INSERTED TO COLLECT GEOMETRY AND LOCAL EGMS. IT WAS DIFFICULT TO COLLECT GEOMETRY AS IT WAS NOT CLEAR WHERE THE CATHETER WAS PLACED IN THE HEART. SOON AFTER THE MAPPING CATHETER WAS PLACED, ARTERIAL HYPOTENSION WAS NOTED, AND THE PROCEDURE WAS ABORTED. INTRACARDIAC ECHOCARDIOGRAPHY WAS USED TO LOCATE THE EFFUSION. CARDIOPULMONARY RESUSCITATION WAS PERFORMED ALONG WITH ADMINISTRATION OF AN EPINEPHRINE DRIP, FOLLOWED BY A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. FOLLOWING PERICARDIOCENTESIS, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND WAS CARDIOVERTED. SPONTANEOUS CIRCULATION RESUMED, AND THE PATIENT WAS NOTED TO BE IN SUPRAVENTRICULAR TACHYCARDIA. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, AND WAS STABLE AND OFF VENTILATION ON (B)(6) 2021.

  Patient problems: Cardiac Perforation

  MAUDE report 11312040 ↗
• MalfunctionAug 2, 2018Material Separation; Material Separation

  THE SHAFT OF THE CATHETER WAS NOTED TO BE SEPARATED / DETACHED AT THE END OF THE STUDY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7743580 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2018-00186, 3008452825-2018-00189, 3008452825-2018-00190, 3005334138-2018-00171, 3008452825-2018-00191, 3005334138-2018-00172, 3005334138-2018-00173. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. DURING ROUTINE ECHOCARDIOGRAPHY A SMALL EFFUSION WAS DIAGNOSED. THE PATIENT'S BLOOD PRESSURE WAS STABLE. OCTAPLEX WAS ADMINISTERED TO REVERSE ANTICOAGULANT THERAPY AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT. THE PATIENT RECOVERED AND WAS STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 7633504 ↗