Fast-Cath™ 406244Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734014670), received between Oct 23, 2018 and Oct 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. 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.

• InjuryOct 23, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-ABBOTT 6FR DIAGNOSTIC ELECTROPHYSIOLOGY (EP) CATHETER WAS ATTEMPTED TO BE USED WITH A 7FR FAST-CATH HEMOSTASIS INTRODUCER; HOWEVER, RESISTANCE WAS MET. THE EP CATHETER WAS REMOVED AND THE DILATOR AND GUIDEWIRE OF THE FAST-CATH INTRODUCER WAS REINTRODUCED BUT HAD ALSO MET RESISTANCE. THEREFORE THE DEVICE WAS REMOVED. UPON REMOVAL, THE DEVICE BROKE INTO TWO PIECES LEAVING THE DISTAL PART INSIDE THE PATIENTS LEFT FEMORAL VEIN. SINCE THE DEVICE WAS UNABLE TO BE RETRIEVED, A CUT-DOWN SURGERY WAS PERFORMED AND THE DISTAL PART OF THE DEVICE WAS REMOVED. THE INCISION SITE WAS SUTURED CLOSED AND THE PROCEDURE WAS CANCELLED. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7996780 ↗