NC Quantum Apex™ H7493912408400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729783190), received between Mar 28, 2019 and Feb 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionFeb 4, 2022Break; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Break; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 8MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT CROSS THE LESION AND FOUND THAT THE SHAFT GOT BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BROKE 42 CENTIMETERS FROM THE HUB AND THE BALLOON WAS REMOVED BY PULLING THE REMAINING SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453090 ↗
• MalfunctionDec 12, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AN 8MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING ADVANCEMENT THROUGH A WATCHDOG DEVICE, THE SHAFT KINKED AND BROKE OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9461236 ↗
• MalfunctionMar 28, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND ON THE DEVICE. DURING PREPARATION, WHEN A 8MM X 4.00MM NC QUANTUM BALLOON CATHETER WAS OPENED, A LARGE PIECE OF BLUE FUZZ WAS FOUND ON IT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8459626 ↗