Dissector MID1 (REF A000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143902017), received between Mar 8, 2024 and Mar 8, 2024 — 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.

• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A THORACOSCOPIC LEFT ATRIAL APPENDAGE EXCLUSION AND LEFT PULMONARY VEIN ISOLATION, DURING WHICH A MID1 DISSECTOR WAS USED. PRIOR SURGICAL HISTORY INCLUDED AN AORTIC ANEURYSM REPAIRED WITH STENT. POOR VISIBILITY WAS NOTED WITH SINGLE-LUNG VENTILATION. SURGEON ATTEMPTED TO DISSECT BETWEEN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND THE LEFT PULMONARY ARTERY USING THE MID1, BUT BLEEDING OCCURRED. SITE OF BLEEDING SITE COULD NOT BE IDENTIFIED, SO A SMALL INCISION WAS MADE IN THE LEFT FOURTH INTERCOSTAL SPACE AND CARDIOPULMONARY BYPASS WAS INITIATED. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE BUT WAS STABILIZED. BLEEDING FROM THE INFERIOR VENA CAVA (IVC) WAS IDENTIFIED AND REPAIRED WITH ONE PLEDGETED SUTURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 18871020 ↗