NC Quantum Apex™ H7493912415220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729783343), received between Feb 12, 2019 and Feb 12, 2019 — classified as 1 malfunction.

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

• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THE SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5X16MM SYNERGY STENT WAS SUCCESSFUL DEPLOYED IN THE LAD, HOWEVER, IT WAS NOTED THAT A PLAQUE SHIFT INTO THE DIAGONAL OCCURRED. A SECOND WIRE WAS THEN PLACED IN THE DIAGONAL WITH THE STENT DELIVERY SYSTEM STILL PLACED IN THE LAD. A 15MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED; HOWEVER, THE DEVICE MET RESISTANCE INSIDE THE GUIDE WITH THE STENT DELIVERY SYSTEM ALONG WITH THE TWO WIRES INSIDE THE GUIDE CATHETER. THE PHYSICIAN PULLED BACK THE NC QUANTUM APEX BALLOON CATHETER BUT THE SHAFT SEPARATED AT THE MONORAIL JUNCTION INSIDE THE GUIDE CATHETER. THE PHYSICIAN WAS ABLE TO UTILIZE THE STENT DELIVERY SYSTEM TO PULL IT BACK INTO THE GUIDE AND REMOVED EVERYTHING FROM THE PATIENT. THE SAME TWO WIRES WITH TWO DIFFERENT BALLOONS WERE USED TO COMPLETE THE PROCEDURE USING A KISSING BALLOON TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330852 ↗