Advance G30859Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002308593), received between Nov 8, 2018 and Apr 20, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY, AN ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER RUPTURED PRIOR TO REACHING NOMINAL PRESSURE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14162481 ↗
• InjuryApr 2, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE INVOLVING THE RIGHT SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER RUPTURED CIRCUMFERENTIALLY AND SEPARATED IN THE PATIENT UPON REMOVAL OF THE DEVICE. THE BALLOON WAS INFLATED WITH 5.2 MILLILITERS OF CONTRAST AND TWELVE MILLILITERS OF SALINE, USING A COOK INFLATION DEVICE. THE BALLOON RUPTURED PRIOR TO REACHING NOMINAL PRESSURE. NEGATIVE PRESSURE WAS MAINTAINED UPON WITHDRAWAL OF THE CATHETER; HOWEVER, A COUNTERCLOCKWISE ROTATION OF THE CATHETER WAS NOT CONDUCTED. THE ANATOMY WAS NOT TORTUOUS OR ANGULATED, BUT WAS REPORTEDLY HIGHLY CALCIFIED. THE TIP OF THE DEVICE REMAINED IN THE PATIENT, AS AN ATTEMPT TO REMOVE THE BALLOON WAS UNSUCCESSFUL. THE PATIENT HAD RECEIVED HEPARIN DURING THE PROCEDURE; THEREFORE, ADDITIONAL ATTEMPTS TO RETRIEVE THE BALLOON WERE NOT MADE, AND THE PATIENT WAS HOSPITALIZED. AN ULTRASOUND WAS PERFORMED, AND THE PHYSICIAN CONFIRMED THE PRESENCE OF A PULSE IN THE LEG VIA DOPPLER. A FOLLOW-UP PROCEDURE WILL BE SCHEDULED TO REMOVE THE SEPARATED PORTION OF THE DEVICE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE CATHETER MATERIAL WAS ALSO FOUND TO HAVE SEP

  Patient problems: Foreign Body In Patient

  MAUDE report 11609922 ↗
• InjuryNov 8, 2018Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED, WHILE UNDERGOING AN ANGIOPLASTY PROCEDURE OF THE RIGHT LEG VIA THE LEFT COMMON FEMORAL ARTERY, A MALE PATIENT OF UNSPECIFIED AGE EXPERIENCED RETENTION OF A PIECE OF A RUPTURED ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER. THE CONTRAST-FILLED BALLOON WOULD NOT DEFLATE, CONTRAST TYPE AND RATIO WAS NOT SPECIFIED. THE PHYSICIAN OPENED ANOTHER INFLATION DEVICE IN AN ATTEMPT TO DEFLATE THE COMPLAINT BALLOON AND RE-SHEATH IT BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO INTENTIONALLY RUPTURE THE COMPLAINT BALLOON AND, DURING REMOVAL THROUGH A 6FR ANSEL SHEATH, A PART OF THE BALLOON TORE AND BECAME LODGED IN THE PATIENT'S ANATOMY. THE RUPTURED PIECE MEASURED APPROXIMATELY 7CM AND TWO STENTS WERE DEPLOYED IN ORDER TO SECURE THE PIECE AGAINST THE VESSEL WALL. THE STENTING REQUIRED AN ADDITIONAL INCISION IN THE PATIENT'S RIGHT GROIN. AFTER THE STENTS WERE PLACED, NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8052508 ↗