PROGREAT MC*PV2415YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350718440), received between Mar 5, 2024 and Mar 5, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMar 5, 2024Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking; Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A 6 FRENCH 90CM DESTINATION SHEATH WAS PLACED INTO THE LEFT BRACHIAL ARTERY AND EXTENDED INTO THE DISTAL AORTA. AN 035 RUBICON CATHETER WAS PLACED INTO A SMALL BRANCH OFF THE RIGHT INTERNAL ILIAC ARTERY AND A 018 THRUWAY WIRE WAS PLACED. THE 2.4 FRENCH PROGREAT WAS PLACED OVER THE WIRE WITH GREAT RESISTANCE FELT BY THE TECHNOLOGIST LOADING IT. IT WAS NOTED BY THE PHYSICIAN THAT THE TECHNOLOGIST WAS ACCIDENTALLY PINNING THE CATHETER TIP AND PUSHING THE BACK END OF THE CATHETER. AFTER THE TECHNOLOGIST REPOSITIONED THEIR HANDS, THE CATHETER WAS ABLE TO BE DELIVERED TO THE APPROPRIATE LOCATION OVER THE WIRE. THE WIRE WAS REMOVED, AND THE 018 10CM HYDOPACK COIL WAS INTRODUCED. ONE COIL WAS SUCCESSFULLY DELIVERED. THE SECOND COIL WAS DELIVERED; HOWEVER, INTENDED TO BE REPOSITIONED AND UPON REMOVAL, THE COIL BECAME DETACHED DUE TO RESISTANCE AND THE TAIL OF THE COIL WAS HANGING INTO THE COMMON ILIAC ARTERY IN AN UNWANTED LOCATION. THE PROGREAT WAS REMOVED; HOWEVER, IT WAS ELONGATED AND PARTIALLY TORN. THE PHYSICIAN DECIDED THAT NO ADDITIONAL INTERVENTION WAS NECESSARY AT THIS TIME. THE PROCEDURE PERFORMED WAS A TYPE 2 ENDOLEAK EMBOLIZATION OF RIGHT INTERNAL

  Patient problems: Insufficient Information

  MAUDE report 18838280 ↗
• InjuryMar 5, 2024Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking; Stretched; Material Split, Cut or Torn; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A 6 FRENCH 90CM DESTINATION SHEATH WAS PLACED INTO THE LEFT BRACHIAL ARTERY AND EXTENDED INTO THE DISTAL AORTA. AN 035 RUBICON CATHETER WAS PLACED INTO A SMALL BRANCH OFF THE RIGHT INTERNAL ILIAC ARTERY AND A 018 THRUWAY WIRE WAS PLACED. THE 2.4 FRENCH PROGREAT WAS PLACED OVER THE WIRE WITH GREAT RESISTANCE FELT BY THE TECHNOLOGIST LOADING IT. IT WAS NOTED BY THE PHYSICIAN THAT THE TECHNOLOGIST WAS ACCIDENTALLY PINNING THE CATHETER TIP AND PUSHING THE BACK END OF THE CATHETER. AFTER THE TECHNOLOGIST REPOSITIONED THEIR HANDS, THE CATHETER WAS ABLE TO BE DELIVERED TO THE APPROPRIATE LOCATION OVER THE WIRE. THE WIRE WAS REMOVED, AND THE 018 10CM HYDOPACK COIL WAS INTRODUCED. ONE COIL WAS SUCCESSFULLY DELIVERED. THE SECOND COIL WAS DELIVERED; HOWEVER, INTENDED TO BE REPOSITIONED AND UPON REMOVAL, THE COIL BECAME DETACHED DUE TO RESISTANCE AND THE TAIL OF THE COIL WAS HANGING INTO THE COMMON ILIAC ARTERY IN AN UNWANTED LOCATION. THE PROGREAT WAS REMOVED; HOWEVER, IT WAS ELONGATED AND PARTIALLY TORN. THE PHYSICIAN DECIDED THAT NO ADDITIONAL INTERVENTION WAS NECESSARY AT THIS TIME. THE PROCEDURE PERFORMED WAS A TYPE 2 ENDOLEAK EMBOLIZATION OF RIGHT INTERNAL

  Patient problems: Insufficient Information

  MAUDE report 18838156 ↗