Advance G44144Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002441446), received between Sep 14, 2018 and Sep 14, 2018 — classified as 1 malfunction.

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

• MalfunctionSep 14, 2018Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED, WHILE INFLATING THE 12X4 ATB ADVANCE BALLOON CATHETER, IT RUPTURED CIRCUMFERENTIALLY AT 14 ATMOSPHERES DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE BRACHIAL BASILIC ARTERIOVENOUS FISTULA. THIS WAS A VERY RESISTANT LESION. THE PHYSICIAN HAD USED A CUTTING BALLOON PRIOR TO USING THE COMPLAINT DEVICE TO HELP WITH DILITATION. PART OF THE BALLOON SEPARATED BEING LEFT IN THE PATIENT. THE PART LEFT IN THE PATIENT WAS THEN STUCK ON THE HYDRO ST WIRE. PHYSICIAN WAS THEN ABLE TO REMOVE THE WIRE WITH THE BROKEN PART OF BALLOON STUCK ON THE WIRE. THE SHEATH HAD TO BE REMOVED AS WELL. HEMOSTASIS WAS ACHIEVED USING MANUAL PRESSURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE. ACCORDING TO THE COMPLAINANT, ISOVUE 300 CONTRAST WAS USED IN A 70/30 MIXTURE WITH SALINE DURING THE PROCEDURE. THERE WAS NO VESSEL ANGULATION OR CALCIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878673 ↗