i-ED COIL 390-0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04540778176430), received between Jan 20, 2021 and Jan 20, 2021 — 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. 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.

• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACOM WIDE NECK SAH CASE (EMERGENCY SURGERY) SELECT I-ED COMPLEX-ES 3-6 FOR FRAMING. AFTER THAT, TWO I-ED COMPLEX-SS 2-2 WERE PLACED, AND THEN I-ED COMPLEX-SS 1-2 WAS SELECTED. ACCORDING TO THE DOCTOR IN CHARGE, THE MICROCATHETER WAS IN A VERY UNSTABLE STATE AS IT WENT OUT OF THE ANEURYSM DURING INSERTION. IN ADDITION, ALTHOUGH THE COIL COULD BE PLACED SOMEHOW, THE LOOP SHOOK A LITTLE AND IT SEEMED THAT IT WAS NOT ENTANGLED, BUT WHEN THE COIL WAS DETACHED AS IT WAS, THE COIL DEVIATED FROM THE ANEURYSM. THE DOCTOR IN CHARGE TRIED TO WITHDRAW THE DEVIATED COIL, BUT DECIDED THAT THE EXTENT OF THE INFARCTION WOULD BE SMALL BECAUSE THE COIL HAD MOVED TO THE DISTAL PART OF THE BLOOD VESSEL, AND ABANDONED THE WITHDRAWING. THE MICROCATHETER WAS REINSERTED INTO THE ANEURYSM AND TWO I-ED COMPLEX-SS WERE PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11200261 ↗