Advance G34336Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002343365), received between May 31, 2017 and May 13, 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.

• InjuryMay 13, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED, A FEMALE PATIENT AGED (B)(6) WAS UNDERGOING A VENOGRAM OF THE RIGHT SUBCLAVIAN VEIN. ACCESS WAS GAINED VIA THE LEFT INTERNAL JUGULAR VEIN, LEFT FEMORAL VEIN, AND RIGHT BRACHIAL VEIN IN ORDER TO TREAT A FULLY OCCLUDED LESION IN THE RIGHT SUBCLAVIAN VEIN. THE PHYSICIAN WAS ABLE TO PASS THROUGH THE OCCLUSION AND ATTEMPTED TO BALLOON WITH OTHER VENDORS' BALLOONS, SEVERAL OF WHICH BURST. THE FIRST OF TWO ADVANCE 18 LP LOW PROFILE BALLOON CATHETERS (PTA4-18-150-6-2) WAS SUBSEQUENTLY USED AND BURST BY PHYSICIAN PREFERENCE FOR THE PURPOSE OF ACCESS. THIS DEVICE WAS REMOVED AND A SECOND ADVANCE 18 LP LOW PROFILE BALLOON CATHETER (PTA4-18-150-6-8) WAS USED WHICH ALSO BURST, UNDESIRABLY, IN HALF. ONE HALF OF THIS BALLOON WAS LEFT IN THE PATIENT'S ANATOMY, REPORTEDLY CAUSING "PROBLEMS" WHILE TREATING, AND STENTED AGAINST THE VESSEL WALL. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE WAS ORIGINALLY PLANNED TO INCLUDE STENTING OF THE OCCLUDED VESSEL. ALTHOUGH THESE OCCURRENCES INCREASED THE PROCEDURE TIME, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A GOOD RESULT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION PROVIDED BY THE COOK REPRESENTATIVE

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8605088 ↗
• MalfunctionMay 31, 2017Crack; Material Separation; Crack; Material Separation

  IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM PROCEDURE USING AN ADVANCE 18 LOW PROFILE BALLOON CATHETER, THE HUB OF THE CATHETER SEPARATED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6602576 ↗