Prelude® 10884450330590Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450330590), received between Mar 6, 2020 and Aug 18, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE ACCOUNT ALLEGES A PACKAGING DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A PROCEDURE. THE DEVICE WAS NOT USE. NO PATIENT CONTACT OR INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10423578 ↗
• InjuryMar 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION [PCI] PROCEDURE, A FOREIGN OBJECT WAS IDENTIFIED WITH IN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S AORTIC ARCH TO CANNULATE AND OPACIFY THE PATIENT'S RIGHT CORONARY ARTERY [RCA]. DURING THE CORONARY ANGIOGRAPHY A SLIGHTLY TAPERED FOREIGN BODY IN THE AREA OF THE PROXIMAL RCA WAS IDENTIFIED. THE PHYSICIAN ALLEGES THAT IT MAY BE THE MARKER BAND OF THE SHEATH THAT DETACHED AND WAS CARRIED INTO THE RCA BY THE GUIDE CATHETER. NO PATIENT CONSEQUENCES TO REPORT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. A BALLOON CATHETER WAS THEN INTRODUCED ALONG THE GUIDEWIRE AND INFLATED TO RETRIEVE THE FOREIGN OBJECT FROM THE HEART. WHEN TRYING TO REMOVE THE FOREIGN OBJECT THROUGH THE FEMORAL ACCESS SHEATH, THE FOREIGN BODY DETACHED FORM THE BALLOON AND MIGRATED IN AN ANTEGRADE DIRECTION INTO THE LATERAL BRANCH OF THE PROFUNDA ARTERY. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT'S PERIPHERY. THE PATIENT REMAINS ASYMPTOMATIC.

  Patient problems: Foreign Body In Patient

  MAUDE report 9799441 ↗