PROGREAT MC*PC2013YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350727367), received between Dec 12, 2024 and Dec 12, 2024 — 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.

• InjuryDec 12, 2024Break; Break

  TERUMO MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE EVENT DESCRIPTION STATES: "WHILE REMOVING THE FATHOM WIRE THROUGH THE PRO GREAT MICROCATHETER, PART OF THE TIP OF THE WIRE (7-10CM) BROKE OFF IN THE ARTERY AND WAS UNABLE TO BE REMOVED DESPITE ATTEMPT VIA SNARE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: Y 90 RADIOEMBOLIZATION. SELECTIVE CATHETERIZATION CELIAC ARTERY FOR CELIAC ARTERY ANGIOGRAM. ORIGINAL INTENDED PROCEDURE: SUPERSELECTIVE CATHETERIZATION OF THE RIGHT HEPATIC ARTERY FOR RIGHT HEPATIC ARTERY ANGIOGRAM AND CONED BEAM CT. CONE BEAM DYNA CT WITH CATHETER POSITIONED IN HEPATIC ARTERIES WITH ADDITIONAL 3-D IMAGE POSTPROCESSING. TRANSARTERIAL DELIVERING Y90 SIRSHPHERES IN SUPERSELECTIVE RIGHT HEPATIC ARTERY. ULTRASOUND GUIDANCE FOR ARTERIAL ACCESS. LIMITED RIGHT COMMON FEMORAL ARTERY ANGIOGRAM AND CLOSURE DEVICE DEPLOYMENT FOR HEMOSTASIS".

  Patient problems: Foreign Body In Patient

  MAUDE report 20914171 ↗
• InjuryDec 12, 2024Break; Break

  TERUMO MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE EVENT DESCRIPTION STATES: "WHILE REMOVING THE FATHOM WIRE THROUGH THE PRO GREAT MICROCATHETER, PART OF THE TIP OF THE WIRE (7-10CM) BROKE OFF IN THE ARTERY AND WAS UNABLE TO BE REMOVED DESPITE ATTEMPT VIA SNARE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: Y 90 RADIOEMBOLIZATION. SELECTIVE CATHETERIZATION CELIAC ARTERY FOR CELIAC ARTERY ANGIOGRAM. ORIGINAL INTENDED PROCEDURE: SUPERSELECTIVE CATHETERIZATION OF THE RIGHT HEPATIC ARTERY FOR RIGHT HEPATIC ARTERY ANGIOGRAM AND CONED BEAM CT. CONE BEAM DYNA CT WITH CATHETER POSITIONED IN HEPATIC ARTERIES WITH ADDITIONAL 3-D IMAGE POSTPROCESSING. TRANSARTERIAL DELIVERING Y90 SIRSHPHERES IN SUPERSELECTIVE RIGHT HEPATIC ARTERY. ULTRASOUND GUIDANCE FOR ARTERIAL ACCESS. LIMITED RIGHT COMMON FEMORAL ARTERY ANGIOGRAM AND CLOSURE DEVICE DEPLOYMENT FOR HEMOSTASIS."

  Patient problems: Foreign Body In Patient

  MAUDE report 20914014 ↗