NC Quantum Apex™ H7493912415500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729783435), received between May 17, 2019 and Dec 20, 2019 — classified as 2 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 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.

• MalfunctionDec 20, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. A 15MM X 5.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON ENTERING A 0.14 UNKNOWN GUIDE WIRE INTO THE CATHETER, THE BALLOON SHAFT WAS STUCK ON THE WIRE IN THE GUIDE CATHETER AND AS THE PHYSICIAN WAS PUSHING THE DEVICE, THE CATHETER BROKE. THE PHYSICIAN WAS ABLE TO REMOVE EVERYTHING AS HE PULLED BACK THE WIRE. A NEW WIRE AND A 20X5.00MM BALLOON WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY CALCIFIED VESSEL OF THE LEFT LEG. THE DEVICE WAS FRACTURED MID SHAFT AND WAS REMOVED WITH THE GUIDE WIRE AND GUIDE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503892 ↗
• MalfunctionMay 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 15 MM X 5.00 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE BALLOON BROKE OFF. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8620704 ↗