NC Quantum Apex™ H7493912412450Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729783312), received between Sep 20, 2019 and Dec 16, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR ANGIOPLASTY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED OSTIUM OF THE LEFT MAIN. A 12MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION OF A PREVIOUSLY PLACED STENT. HOWEVER, DURING THE SECOND INFLATION AT 11 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000544 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 12MM X 4.50MM NC QUANTUM APEX BALLOON SHAFT BROKE WHILE BEING INTRODUCED INTO THE GUIDE CATHETER. THE NC QUANTUM APEX BALLOON WAS SAFELY REMOVED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754121 ↗
• MalfunctionJun 15, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE INSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14702612 ↗
• MalfunctionJun 15, 2022Material Rupture; Physical Resistance/Sticking; Material Rupture; Physical Resistance/Sticking

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON WAS TORN WHEN PUSHING IT ON THE NON-BOSTON SCIENTIFIC WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14701149 ↗
• MalfunctionSep 20, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT WERE ENCOUNTERED. AN UNKNOWN STENT WAS PLACED IN THE MIDDLE OF AN UNKNOWN VESSEL BUT WAS NOT FULLY EXPANDED. A NON-BSC BALLOON WAS INFLATED THREE TIMES, HOWEVER, IT BURST. A 12MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS THEN INFLATED, HOWEVER, DURING THE SECOND INFLATION, AT APPROXIMATELY 34 ATMOSPHERES, IT ALSO BURST. IT WAS NOTED THAT THE TIP WITH THE MARKER, CAME OFF WHEN THE BALLOON BURST. THE MARKER AND THE FRAGMENT WERE REMOVED BY PULLING THE GUIDE AND THE SHEATH OUT OF THE ACCESS SITE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9100569 ↗