Prelude IDeal™ 10884450317379Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884450317379), received between Nov 27, 2019 and Mar 25, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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 18, 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 25, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERCUTANEOUS TRANSLUMINAL ASSESS FOR A MEDICAL PROCEDURE, THE HUB OF THE INTRODUCER DETACHED WHEN THE CLINICIAN WAS ATTEMPTING TO REMOVE THE ACCESS GUIDEWIRE AND THE INTRODUCER. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9881121 ↗
• MalfunctionMar 25, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERCUTANEOUS TRANSLUMINAL ASSESS FOR A MEDICAL PROCEDURE, THE HUB OF THE INTRODUCER DETACHED WHEN THE CLINICIAN WAS ATTEMPTING TO REMOVE THE ACCESS GUIDEWIRE AND THE INTRODUCER. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9881110 ↗
• MalfunctionMar 19, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTIONAL PROCEDURE, THE HUB ON THE INTRODUCER DETACHED WITHIN THE INTRODUCER SHEATH. THE CLINICIAN HAD ACQUIRED VASCULAR ACCESS [VIA SELDINGER TECHNIQUE] WITH THE INTRODUCER SHEATH. DURING REMOVAL OF THE INTRODUCER ALONG WITH THE ACCESS GUIDEWIRE, THE INTRODUCER SHEATH HUB DETACHED FROM THE INTRODUCER LEAVING THE INTRODUCER WITHIN THE ACCESS SHEATH. THE CLINICAL WAS ABLE TO SAVE THE PRIMARY ACCESS SITE AND SHEATH FOR THE CHRONIC TOTAL OCCLUSION [CTO] PROCEDURE BY USING A VASCULAR SNARE DEVICE THAT HAD ALREADY BEEN PREPPED AND SITTING WITHIN THE STERILE FIELD INSTEAD OF USING A PAIR OF FORCEPS. RETRIEVAL WAS SUCCESSFUL, AND THE PRIMARY ACCESS SITE AND SHEATH WERE USED TO COMPLETE THE CTO PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857538 ↗
• InjuryNov 27, 2019Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A MEDICAL PROCEDURE, AN ACCESS GUIDEWIRE TIP DETACHED WITHIN THE PATIENT. THE DETACHED TIP MIGRATED INTO THE PATIENT'S ABDOMINAL AORTA. THE PHYSICIAN REMOVED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385105 ↗