Fountain® 00884450012277Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450012277), received between May 6, 2021 and May 6, 2021 — classified as 1 injury.

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 18, 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.

• InjuryMay 6, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL THROMBOLYTIC PROCEDURE ON A PATIENT DIAGNOSED WITH PERIPHERAL VASCULAR DISEASE [PVD], THE THROMBOLYTIC CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS AND HAD SUCCESSFULLY NEGOTIATED THE PATIENTS CHALLENGING AND DISEASED VASCULATURE UNDER FLUOROSCOPY. THE THROMBOLYTIC CATHETER WAS SUCCESSFULLY PLACED WITHIN THE PATIENT'S SUPERFICIAL FEM-POP ARTERY IN AN ATTEMPT TO RESTORE PATIENT'S BLOOD FLOW TO THE LOWER PERIPHERY. DURING REMOVAL OF THE THROMBOLYTIC CATHETER FOR FOLLOW-UP IMAGING, THE TIP DETACHED WITHIN THE PATENT'S LOWER EXTREMITY. THE ACCOUNT STATES THAT AN ATTEMPT TO RETRIEVE THE FOREIGN BODY IN TOTAL, MAY NOT HAVE BEEN COMPLETELY SUCCESSFUL. POST PERIPHERAL VASCULAR INTERVENTION, THE PATIENT UNDERWENT A LOWER EXTREMITY (LE) AMPUTATION BECAUSE OF THE UNSUCCESSFUL THROMBOLYTIC THERAPY ATTEMPTS. THE ACCOUNT STATES THAT THE AMPUTATION WAS NECESSARY DUE TO THE CURRENT DISEASE STATE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787791 ↗