NC Quantum Apex™ H7493912412400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729783305), received between Jan 10, 2017 and Apr 11, 2023 — classified as 1 injury, 4 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 12MM X 4.00MM NC QUANTUM APEX WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION OF THE TARGET LESION LOCATED IN THE LEFT MAIN ARTERY. HOWEVER, UPON OPENING THE PACKAGE, THERE WAS NO STERILE POUCH IN THE BOX AND THE BALLOON HOOP AND INFLATION CARD WERE JUST SITTING IN THE BOX. THE DEVICE WAS NOT USED DURING THE PROCEDURE SINCE IT WAS CONSIDERED UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714448 ↗
• InjuryOct 8, 2019Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND DEVICE FRACTURE OCCURRED. A 12 MM X 4.00 MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION OF A CALCIFIED LESION. DURING INFLATION, THE BALLOON RUPTURED AND WHEN THE DEVICE WAS BEING REMOVED, IT FRACTURED. ANOTHER BALLOON WAS PINNED IN THE GUIDE TO PULL OUT THE FRACTURED BALLOON AND COMPLETE THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9170089 ↗
• MalfunctionJan 30, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 12X4.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 12MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO TORTUOSITY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290200 ↗
• MalfunctionDec 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 12MM X 4.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USED TO DILATE THE LESION; HOWEVER, IT WAS NOTED THAT THE BALLOON RIPPED OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8182292 ↗
• MalfunctionJan 10, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CATHETER INTERVENTION PROCEDURE, CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RAMUS INTERMEDIUS. A 4.00X12MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED TO THE LESION. AFTER DILATION WITH 22 BAR, THE BALLOON CATHETER WAS REMOVED, BUT IT ENTRAPPED ON THE GUIDEWIRE. BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6239510 ↗