Fountain® 00884450011676Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450011676), received between Oct 26, 2021 and Aug 31, 2022 — classified as 1 injury, 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 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 31, 2022Fracture; Material Separation; Material Twisted/Bent; Fracture; Material Separation; Material Twisted/Bent

  THE ACCOUNT ALLEGES THAT DURING AN ELECTIVE PROCEDURE FOR PERIPHERAL ARTERIAL OCCLUSION BETWEEN RIGHT FEMORAL AND POPLITEAL ARTERIES THE WIRE BROKE WHILE REMOVING. ALTHOUGH THE VESSELS HAD CALCIFICATION, NO SIGNIFICANT TORTUOSITY HAS NOT BEEN FOUND. CONTRALATERAL APPROACH FROM LEFT FEMORAL ARTERY WAS USED FOR THE PROCEDURE. AFTER THE COMPLETION OF THE INFUSION WITH THE INFLUSION CATHETER, THE OCCLUDING WIRE WAS ATTEMPTED TO BE WITHDRAWN, LEAVING THE INFUSION CATHETER IN THE VESSEL. AT THIS TIME, THE OPERATOR FELT PHYSICAL RESISTANCE AT THE VICINITY OF A Y-CONNECTOR AT THE OPERATOR'S [PROXIMAL] END OF THE PRODUCT. HOWEVER, THE OPERATOR PULLED THE WIRE OUT, AND THE WIRE GOT BROKEN OFF. THE BREAKAGE SITE WAS MORE PROXIMAL TO THE BALL AT THE TIP OF THE WIRE. THE ENTIRE PORTION OF THE WIRE WAS WITHDRAWN OUT WITH THEINFUSION CATHETER, DEEMING THAT THE BALL WITH THE BROKEN PORTION OF THE WIRE WOULD NOT TRANSFER INTO PATIENT'S BODY FROM THE CATHETER TIP. AFTER THE WITHDRAWAL, IT WAS FOUND THAT THE CATHETER HAD KINKED. THE KINK WAS NOT FOUND BEFORE USE. THE PLANNED PROCEDURE WAS COMPLETED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331357 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER PLACING ANTICOAGULATION IN A LEFT ILIAC VENOUS INDWELLING CATHETER TO MAINTAIN VASCULAR ACCESS, THE PATIENT DEVELOPED A HIGH FEVER. BLOOD CULTURE CAME BACK POSITIVE DUE TO LONG TERM USE OF THE DEVICE. THE CATHETER WAS REMOVED AND ANTIBIOTICS ADMINISTERED.

  Patient problems: Unspecified Infection

  MAUDE report 12700111 ↗