Advance G49479Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002494791), received between Jun 16, 2017 and May 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897243 ↗
• MalfunctionJun 16, 2017Material Rupture; Material Separation; Material Rupture; Material Separation

  AN INTERNATIONAL CUSTOMER REPORTED THAT DURING AN ATTEMPTED TREATMENT OF A DISTAL POPLITEAL ARTERY ANGIOPLASTY, SUPERFICIAL FEMORAL ARTERY (SFA) PLASTY, AND COMMON FEMORAL ARTERY (CFA) PLASTY; THE ADVANCE 18 LOW PROFILE BALLOON CATHETER FAILED AND SEPARATED FROM THE CATHETER. THE REPORTER STATED THAT THIS EVENT OCCURRED WITH A VERY TIGHT AORTIC BIFURCATION WHILE USING A CONTRALATERAL APPROACH. THE BALLOON WAS SUCCESSFULLY ADVANCED TO THE TARGET SITE AND INFLATED. IT WAS USED TO ANGIOPLASTY THE SUPERFICIAL FEMORAL ARTERY (SFA) AND DISTAL COMMON FEMORAL ARTERY. WHEN TRYING TO REMOVE THE BALLOON ACROSS THE BIFURCATION, RESISTANCE WAS FELT. IT WAS STATED THAT AS THE CATHETER WAS REMOVED, THE BALLOON APPEARED TO HAVE STRETCHED AND WAS TORN AS A RESULT OF THE STRETCHING. WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THAT THE BALLOON WAS NOT ON THE CATHETER. WHEN THE WIRE WAS REMOVED, THE BALLOON MATERIAL WAS ON THE WIRE. THE CUSTOMER REPORTED THAT THE WIRE WAS A NON-COOK PRODUCT. THE INFLATION PRESSURE USED WAS 12 ATM. THE CONTRAST TO SALINE MIXTURE WAS OMNIPAQUE 30/70. IT WAS UNSURE IF A CLOCKWISE ROTATION WAS USED DURING CATHETER WITHDRAWAL. THE REPORTER STATED THAT ONCE DEFLATED, THE BA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6647499 ↗