PROGREAT MC*PB2813YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350771773), received between May 9, 2018 and Dec 20, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionDec 20, 2019Material Separation; Material Deformation; Material Separation; Material Deformation

  THE USER FACILITY REPORTED THAT AFTER SUCCESSFULLY COILING THE ACCESSORY RENAL, HE ADVANCED THE BMW WIRE (ABBOTT) THROUGH THE SOS OMNI 2 CATHETER AND TRIED TO ADVANCE THE PROGREAT OVER THE WIRE. THEY REMOVED THE PROGREAT TO FLUSH IT, AND A BUBBLE APPEARED AT THE DISTAL END AND IT HAD COME APART. THE REMAINING PART OF THE PROGREAT WAS STILL ON THE WIRE AND REMOVED FROM THE PATIENT. A NEW PROGREAT WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS UNHARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 03DEC2019. IT SEPARATED ON THE WIRE; HOWEVER, BOTH PIECES CAME OUT WITHOUT EFFORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503174 ↗
• InjuryMay 9, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN EMERGENT COILING PROCEDURE, AFTER 6 OR 7 NESTOR COILS WERE DEPLOYED, ON THE LAST COIL DEPLOYMENT, THE PROGREAT DEVICE APPEARED TO PROLAPSE BACK ON ITSELF AS THE SALINE WAS USED TO SHOOT THE COIL FORWARD. UPON FURTHER EXAMINATION, IT APPEARED THAT THE INNER COILING ON THE PROGREAT DEVICE APPEARED TO SEPARATE FROM THE CATHETER ITSELF AND BECAME LODGED IN THE PATIENTS ARTERY. THE CATHETER REMAINED OTHERWISE INTACT HOWEVER, THE CATHETER COILING WAS STILL IN THE PATIENT. IT WAS LEFT IN THE PATIENT AND THE PATIENT WENT ON TO SURGERY AS ORIGINALLY SCHEDULED. DURING THIS SURGERY, THE SURGEON REMOVED THE WIRE FROM THE PATIENT AND SENT THE WIRE ON TO PATHOLOGY. AT THIS TIME, IT IS UNSURE IF THIS WIRE IS PART OF THE PROGREAT CATHETER INNER COIL, OR IF IT IS PART OF THE PRIMARY WIND OF NESTOR COIL. THE PATIENT WAS FINE FOLLOWING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFUL AND THE BLEEDING WAS STOPPED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7497859 ↗