Advance G52368Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002523682), received between Aug 31, 2022 and Aug 31, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Break” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathAug 31, 2022Break; Material Rupture; Break; Material Rupture

  AS REPORTED, DURING AN ANGIOGRAM OF THE AORTA WITH BILATERAL LOWER EXTREMITY RUNOFF, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UNDER NOMINAL PRESSURE AND SEPARATED. ANOTHER MANUFACTURER'S 6 FRENCH SHEATH WAS USED, WHICH WAS THEN UPSIZED TO A 7 FRENCH SHEATH. ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO EIGHT ATMOSPHERES TWO TIMES, FOR THIRTY SECONDS EACH, WITHIN THE RIGHT COMMON ILIAC ARTERY. THE ILIAC ARTERIES WERE REPORTEDLY CALCIFIED, AND THE GROINS WERE SCARRED FROM PREVIOUS SURGICAL PROCEDURES. AFTER THE BALLOON RUPTURED, THE USER ATTEMPTED TO REMOVE THE BALLOON BY ITSELF, THROUGH THE SHEATH. REPORTEDLY, SEVERAL SHEATH-RELATED MANEUVERS WERE MADE IN AN ATTEMPT TO FULLY COLLAPSE THE BALLOON INTO THE SHEATH; HOWEVER, THIS WAS NOT SUCCESSFUL, AND THE USER ATTEMPTED TO PULL THE BALLOON OUT DIRECTLY AND THE TIP OF THE BALLOON/CATHETER SEPARATED. THE DISTAL TIP OF THE DEVICE REMAINED IN THE PATIENT, AND THE DISTAL BALLOON MARKER WAS NOTED AT THE LEVEL OF THE LEFT FEMORAL ACCESS SITE. NUMEROUS MANEUVERS WERE PERFORMED TO UPSIZE THE SHEATH IN THE LEFT GROIN TO AN 8 FRENCH SYSTEM TO SNARE THE SEPARATED PORTION OF THE BALLOON/CATHETER AND RETRA

  Patient problems: Foreign Body In Patient

  MAUDE report 15328423 ↗