PhD™ 00884450160503Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450160503), received between Mar 10, 2021 and Mar 10, 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. 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 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS CORONARY INTERVENTION [PCI], AIR WAS ACCIDENTALLY INJECTED INTO THE PATIENT'S VASCULATURE SYSTEM. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED ARTERIAL ACCESS AND HAD NEGOTIATED THE PATIENT'S CORONARY ARTERY UNDER FLUOROSCOPY WITH A GUIDEWIRE AND AN INTERVENTIONAL GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS COMPLAINING ABOUT A HEMOSTASIS VALVE THAT WAS LEAKING FLUID AND CONTINUED TO USE THE HEMOSTASIS DEVICE. DURING THE PROCEDURE AIR WAS ACCIDENTALLY INJECTED INTO THE PATIENT'S CORONARY ARTERY, ECG CHANGES WERE NOTED AND CONFORMED THAT THE PATIENT WAS EXPERIENCING A MYOCARDIAL INFARCTION [MI] AND THE PROCEDURE WAS STOPPED TO OBSERVE VITAL SIGNS AND HEMODYNAMICS. ACLS AND BASIC LIFE SUPPORTING PROTOCOLS WERE ACTIVATED AND SUCCESSFULLY ADMINISTERED PER HOSPITAL POLICY. ADDITIONAL LIFESAVING INTERVENTIONS, TECHNIQUES, AND MEDICATIONS WERE REQUIRED.

  Patient problems: Air Embolism

  MAUDE report 11455227 ↗