ASCENT BRS000407-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528001928), received between Oct 26, 2016 and Feb 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionFeb 23, 2022Unintended Movement; Unintended Movement

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: KIRMANI JF, PAOLUCCI U. ASCENT¿: A NOVEL BALLOON MICROCATHETER DEVICE USED AS THE PRIMARY COILING MICROCATHETER OF A BASILAR TIP ANEURYSM. J NEUROIMAGING. 2012 APR;22(2):191-3. DOI: 10.1111/J.1552-6569.2011.00619.X. EPUB 2011 JUN 24. PMID: 21707825. OBJECTIVE AND METHODS: THIS ARTICLE DESCRIBES A PREVIOUSLY UNREPORTED NOVEL DEVICE WHERE A BALLOON CATHETER WAS USED AS THE PRIMARY COILING MICROCATHETER, THEREBY ELIMINATING THE NEED FOR ADDITIONAL CATHETERS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 4MM × 7MM ASCENT BALLOON SYSTEM. CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: NI. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: NI. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A 52-YEAR-OLD MALE PRESENTED FOR ELECTIVE ENDOVASCULAR REPAIR OF AN ASYMPTOMATIC 8.5 × 7.1 MM ANTERIORLY POINTING BASILAR TIP ANEURYSM WITH NECK MEASURING 3 MM. PRIOR DIAGNOSTIC CEREBRAL CATHETER ANGIOGRAPHY SUGGESTED BALLOON AND/OR STENT ASSISTANCE MAY BE REQUIRED FOR SATISFACTORY COIL EMBOLIZATION. UNDER ROADMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586906 ↗
• MalfunctionOct 26, 2016Deflation Problem; Deflation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANEURYSM COILING PROCEDURE AN ASCENT BALLOON (BRS00040700/C24907) FAILED TO DEFLATE. THE PHYSICIAN USED A FARGOMAX CATHETER THROUGH WHICH HE NAVIGATED THE PROWLER SELECT LP ES (LOT UNKNOWN) MICROCATHETER AND THE ASCENT BALLOON. AFTER EMBOLIZATION OF THE ANEURYSM WITH COILS (TYPE/LOT UNKNOWN), THE DOCTOR REALIZED THAT THE BALLOON DID NOT DEFLATE. THE BALLOON DEFLATED AFTER SEVERAL ATTEMPTS. IT WAS INITIALLY REPORTED THAT THE DEVICE IS AVAILABLE FOR ANALYSIS. NO FURTHER DETAILS ARE AVAILABLE ON THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6057672 ↗