Advance G30897Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002308975), received between May 17, 2016 and Oct 20, 2020 — classified as 2 injuries.

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 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.

• InjuryOct 20, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE FOR A CHRONIC TOTAL OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE LESION WAS CROSSED USING ANOTHER MANUFACTURER'S CATHETER AND THE LESION WAS PRE-DILATED WITH A COOK 2X6 18LP BALLOON. THE COMPLAINT DEVICE WAS THEN INSERTED OVER A COOK 0.014 INCH ROADRUNNER WIRE GUIDE. THE BALLOON WAS INFLATED TO APPROXIMATELY FIVE OR SIX ATMOSPHERES USING A 50/50 RATIO OF OMNIPAQUE CONTRAST TO SALINE, AT WHICH POINT THE BALLOON RUPTURED. THE USER THEN ATTEMPTED TO REMOVE THE BALLOON OVER THE WIRE; HOWEVER, IT BECAME STUCK, POSSIBLY WITHIN THE HEAVILY CALCIFIED LESION, AND SEPARATED. THE SHEATH AND BALLOON CATHETER WERE REMOVED AS A UNIT. THE DISTAL MARKER AND SEPARATED PORTION OF THE BALLOON WERE LEFT IN THE BODY, WRAPPED AROUND THE WIRE GUIDE. A 6X13 COOK PERFORMER SHEATH WAS THEN INSERTED AND THE USER REMOVED THE SEPARATED PORTION OF THE DEVICE BY PULLING THE WIRE GUIDE AND BALLOON FRAGMENT THROUGH THE SHEATH. 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 D

  Patient problems: No Code Available

  MAUDE report 10706673 ↗
• InjuryMay 17, 2016Material Rupture; Material Rupture

  DURING A ANGIOPLASTY OF SFA PROCEDURE, THE BALLOON RUPTURED CIRCUMFERENTIALLY, THE VESSEL WAS CALCIFIED, AND THE BALLOON WAS INFLATED TO JUST BELOW THE RBP. THE BALLOON PASSED ACROSS THE LESION AND INFLATED TO JUST BELOW RBP. THE BALLOON THEN RUPTURED AND A PORTION OF THE BALLOON SEPARATED FROM THE CATHETER AND WAS LEFT IN THE PATIENT. RETRIEVAL WAS ATTEMPTED BUT UNSUCCESSFUL. THE DECISION MADE TO STENT OVER THE PIECE OF THE BALLOON 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: Foreign Body In Patient

  MAUDE report 5660882 ↗