NC Quantum Apex™ H7493912406270Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729783039), received between Jan 23, 2019 and Jan 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 6MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION DUE TO THE TORTUOUSITY. PRE-DILATATION WAS PERFORMED WITH A SMALLER DIAMETER AND SHORTER LENGTH BALLOON, FOLLOWED BY THE IMPLANTATION OF A STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING ALL RIGHT. HOWEVER, DEVICE ANALYSIS REVEALED NUMEROUS SHAFT PERFORATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8272639 ↗