Prelude EASE™ 10884450289430Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450289430), received between Apr 3, 2020 and Apr 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionApr 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO ACQUIRE PERCUTANEOUS TRANSLUMINAL ACCESS VIA SELDINGER TECHNIQUE, WHEN THE INTRODUCER HUB DETACHED. VASCULAR ACCESS WITH THE 7F INTRODUCER SHEATH WAS ATTEMPTED THROUGH THE PATIENT'S RIGHT RADIAL ARTERY OVER AN .021 ACCESS WIRE. THE PHYSICIAN WAS ATTEMPTING TO REMOVE BOTH THE INTRODUCER, AND THE INTRODUCER ACCESS WIRE TOGETHER FROM THE INTRODUCER SHEATH, WHEN THE HUB DETACHED LEAVING THE REMAINING INTRODUCER WITHIN THE SHEATH. THE REMAINING INTRODUCER WAS REMOVED BY THE PHYSICIAN. A NEW ACCESS SHEATH WAS PLACE AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9920870 ↗