Advance G34330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002343303), received between Jun 6, 2019 and Jul 31, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 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.

• InjuryJul 31, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF A 100% OCCLUDED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND SEPARATED. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY AND AN ANTEGRADE APPROACH WAS USED. A COOK SHEATH AND OTHER MANUFACTURER'S WIRE GUIDE WERE ALSO USED DURING THE PROCEDURE .THE VESSEL WAS MODERATELY CALCIFIED; HOWEVER, ANGULATION AND TORTUOSITY WERE NOT REPORTED. THE BALLOON WAS INFLATED ONE TIME, USING AN UNKNOWN INFLATION DEVICE, WITH A 70/30 RATIO OF VISIPAQUE CONTRAST TO SALINE. THE INFLATION PRESSURE AT THE TIME OF RUPTURE IS UNKNOWN. BLOOD WAS NOTED IN THE INFLATION DEVICE AFTER THE DEVICE RUPTURED. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE SEPARATED PORTION OF THE BALLOON WAS REMOVED WITH A SNARE IN APPROXIMATELY TEN MINUTES. ANOTHER BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 10351291 ↗
• MalfunctionJun 6, 2019Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED ON 31MAY2019 NOTING: AN UNKNOWN 6 FRENCH SHEATH WAS UTILIZED DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS INFLATED TWO TIMES TO 8 ATMOSPHERES FOR 60 SECONDS EACH TIME IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, WITH A 50%/50% RATIO OF VISIPAQUE CONTRAST TO SALINE. THE PATIENT¿S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR ANGULATED; HOWEVER SEVERE CALCIFICATION WAS REPORTED. THE BALLOON WAS NOT INFLATED INSIDE OF A STENT AND WAS NOT REMOVED BETWEEN INFLATIONS. IT IS UNKNOWN IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675978 ↗