FINECROSS 35-1430Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350703163), received between Aug 27, 2019 and Aug 27, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

• InjuryAug 27, 2019Break; Difficult to Remove; Break; Difficult to Remove

  THE USER FACILITY REPORTED THAT INVOLVED FINE CROSS DEVICE WAS STUCK IN LEFT ANTERIOR DESCENDING VESSEL DURING COMPLEX PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE PATIENT WAS SCHEDULED FOR A PERCUTANEOUS CORONARY INTERVENTION AFTER TURNING DOWN CORONARY ARTERY BYPASS GRAFT A YEAR AGO. DIFFUSELY CALCIFIED LEFT ANTERIOR DESCENDING APPRECIATED WITH FLUOROSCOPY. THE FINE CROSS WAS INSERTED, VIPER WIRE INSERTED THROUGH FC, THEN WHEN TRYING TO REMOVE THE FINE CROSS, THE MD NOTICED THE MARKER WAS NOT MOVING. THE MD/STAFF WERE NOT PULLING ON THE MC. THEY DETERMINED THAT APPROXIMATELY 15 CM WERE LEFT IN THE PATIENT; AND WERE UNABLE TO SNARE THE DEVICE. THE PROCEDURE WAS REPORTED TO BE UNSUCCESSFUL. A LEFT MAIN DISSECTION WAS ALSO NOTED. THE PATIENT WENT TO EMERGENCY SURGERY FOR CORONARY ARTERY BYPASS GRAFT. THE PATIENT WAS REPORTED TO BE IN THE ICU IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8935795 ↗
• InjuryAug 27, 2019Break; Difficult to Remove; Break; Difficult to Remove

  THE USER FACILITY REPORTED THAT INVOLVED FINECROSS DEVICE WAS STUCK IN LEFT ANTERIOR DESCENDING VESSEL DURING COMPLEX PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE PATIENT WAS SCHEDULED FOR A PERCUTANEOUS CORONARY INTERVENTION AFTER TURNING DOWN CORONARY ARTERY BYPASS GRAFT A YEAR AGO. DIFFUSELY CALCIFIED LEFT ANTERIOR DESCENDING APPRECIATED WITH FLUOROSCOPY. THE FINECROSS WAS INSERTED, VIPERWIRE INSERTED THROUGH FC, THEN WHEN TRYING TO REMOVE THE FINECROSS, THE MD NOTICED THE MARKER WAS NOT MOVING. THE MD/STAFF WERE NOT PULLING ON THE MC. THEY DETERMINED THAT APPROXIMATELY 15 CM WERE LEFT IN THE PATIENT; AND WERE UNABLE TO SNARE THE DEVICE. THE PROCEDURE WAS REPORTED TO BE UNSUCCESSFUL. A LEFT MAIN DISSECTION WAS ALSO NOTED. THE PATIENT WENT TO EMERGENCY SURGERY FOR CORONARY ARTERY BYPASS GRAFT. THE PATIENT WAS REPORTED TO BE IN THE ICU IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8935793 ↗