FLASH Ostial System OCB5014BARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M917OCB5014BA0), received between Mar 9, 2017 and Feb 2, 2021 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K113775, K120738, K122178, K122379); they may or may not involve this specific model.

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 18, 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.

• InjuryFeb 2, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A TAVR PROCEDURE AND DURING THE PROCEDURE IT WAS DETERMINED THAT DILATATION OF A STENT PLACED IN THE LEFT MAIN CORONARY ARTERY WAS ALSO REQUIRED. ALTHOUGH NOT INDICATED, THE PHYSICIAN ELECTED TO USE THE FLASH OSTIAL SYSTEM DEVICE TO POST DILATE THE STENT. THE OUTER BALLOON WAS INFLATED BEYOND THE RATED BURST VOLUME TO EXPAND THE BALLOON TO A LARGER DIAMETER THAN INTENDED PER THE PRODUCT LABELING. AFTER EXCEEDING THE RATED BURST VOLUME, THE BALLOON RUPTURED, AND AN EDGE DISSECTION WAS NOTED DISTAL TO THE STENT. A COVERED STENT WAS PLACED TO ADDRESS THE DISSECTION AND NO FURTHER CLINICAL SEQUELAE WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 11267528 ↗
• DeathMar 9, 2017Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device Handling Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device Handling Problem

  THE HOSPITAL COURSE FOR THIS CASE WAS PROVIDED AND INDICATED THE FOLLOWING: (B)(6) YEAR OLD WITH HISTORY OF CORONARY ARTERY DISEASE, CABG IN (B)(6) 2010 (LIMA TO LAD THAT FILLS DIAGS AND LCX IN RETROGRADE, CVG TO DIAG AND SVG TO LCX) WITH BIO PROSTHETIC MVR, AFIB ON ELIQUIS, (B)(6), AND CLASS III ANGINA WHO PRESENTED FOR HIGH RISK CARDIAC CATHETERIZATION FOR INTERVENTION TO HER CTO OF THE LM. TODAY, HER PCI WAS COMPLICATED BY RUPTURE OF THE LEFT MAIN CORONARY ARTERY WITH RESULTING HEMOPERICARDIUM. TWO STENTS WERE PLACED IN THE LM INTO THE LAD ACROSS THE LCX. THIS RESULTED IN THE LATERAL WALL INFARCT AND CARDIOGENIC SHOCK. AN IMPELLA WAS ALREADY PLACED GIVEN THE HIGH RISK NATURE OF THIS PCI. WHILE IN THE CATH LAB, THE PATIENT SUFFERED CARDIOPULMONARY ARREST, REQUIRING AN UNKNOWN AMOUNT OF CPR AND EPINEPHRINE. THIS PROCEDURE WAS FURTHER COMPLICATED BY A TYPE A AORTIC DISSECTION EXTENDING TO THE PROXIMAL RIGHT BRACHYCEPHALIC ARTERY. THE PATIENT ARRIVED TO THE CICU INTUBATED AND SEDATED ON PRECEDEX. SHE WAS ACTIVELY RECEIVING DRIP RUNNING AT 5 MCG. PATIENT BECAME BRADYCARDIC DESPITE INCREASING PRESSORS REQUIREMENTS AND WAS RUSHED BACK TO THE CATH LAB. A TVP WAS PLACED. THE IMPELLA WAS

  Patient problems: Death; Perforation of Vessels

  MAUDE report 6394007 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113775, K120738, K122178, K122379. One submission often covers many models, so check the product and lot details in each record.

• Z-2309-2021 · Jul 14, 2021 · Terminated
  FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA