NC Quantum Apex™ H7493912412270Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729783251), received between Sep 25, 2018 and Jun 23, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USED. DURING THE PROCEDURE, THE DEVICE WAS OBSERVED TO BE BROKEN OR FRACTURED. ANOTHER BALLOON OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591750 ↗
• MalfunctionMay 10, 2023Break; Inflation Problem; Material Rupture; Break; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE IT WAS NOTICED THAT THE BALLOON WAS LOST IN PRESSURE AND RUPTURED. THE DEVICE WAS THEN PULLED OUT FROM THE PATIENT BODY WITHOUT ANYTHING LEFT OR NEEDING TO BE SNARED OR RETRIEVED; BUT THE SHAFT FOUND SNAPPED ON THE PROXIMAL PORTION OF THE CATHETER NEAR THE HUB. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. FURTHERMORE, THE BALLOON DID NOT RUPTURE. THE DEVICE WAS INFLATED AT 12 ATMOSPHERES AND THE BALLOON WOULD NO LONGER INFLATE DUE TO THE FRACTURE ON THE PROXIMAL END OF THE CATHETER NEAR THE HUB. THE BREAK OCCURRED 3-4 CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902023 ↗
• InjuryFeb 23, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY(LAD). A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS USED IN POST DILATION. HOWEVER, UPON WITHDRAWAL OF THE DEVICE, THE PHYSICIAN NOTICED THAT THE DISTAL SHAFT AND PROXIMAL SHAFT WAS DETACHED FROM THE BI-SEGMENT SHAFT. THE DETACHED SHAFT WAS SNARED AND RETRIEVED FROM THE MID LAD. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588737 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE OFF WHILE PULLING OUT THE BALLOON. SHAFT WAS REMOVED SUCCESSFULLY WITH HEMOSTATS AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526873 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809218 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE PROXIMAL SHAFT OF STAINLESS STEEL HYPOTUBE WAS BROKE IN HALF INSIDE GUIDING CATHETER AND THE BROKE WAS APPROXIMATELY 30CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND ANOTHER NC BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187143 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, UPON PULLING NEGATIVE PRESSURE, AN AIR EMBOLUS WAS INJECTED INTO THE CORONARY ARTERY. THE BALLOON WAS REMOVED AS RUPTURE WAS SUSPECTED, BUT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THE BALLOON WAS INTACT AND THEY FOUND A LEAK IN THE DELIVERY LINE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS THEN TREATED WITH MEDICATIONS AND WAS NOW STABLE.

  Patient problems: Air Embolism

  MAUDE report 9712383 ↗
• MalfunctionFeb 10, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION IS LOCATED IN THE RIGHT CORONARY ARTERY. FOLLOWING STENT IMPLANTATION, A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, WHILE INSERTING THE DEVICE INTO THE GUIDE, THE BALLOON CATHETER BROKE HALFWAY FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688363 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER AND IT WAS NOTICED THAT IT WAS BENT. THE PHYSICIAN REINSERTED THE DEVICE AND THE SHAFT BROKE IN HALF WITH ONE HALF INSIDE THE GUIDE CATHETER AND THE OTHER HALF ON THE TABLE. SINCE THERE WERE TWO OTHER WIRES INSIDE THE GUIDE, ANOTHER BALLOON WAS INFLATED ON ONE OF THOSE WIRES AND THEN EVERYTHING WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT BALLOON AND GUIDE CATHETERS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429844 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER, THE SHAFT OF THE BALLOON APPEARED TO BE KINKED WHEN IT WAS TAKEN OUT FROM THE HOOP. THE PHYSICIAN THEN ATTEMPTED TO STRAIGHTEN IT, BUT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 8381339 ↗
• MalfunctionSep 25, 2018Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-AUG-2018. IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT WAS KINKED AND CUT OFF AT 4-5CM JUST BEFORE THE HEMOSTATIC VALVE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW NC QUANTUM APEX BALLOON CATHETER AND IMPLANTATION OF A STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED. RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER IN TWO PIECES. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE MICROSCOPICALLY EXAMINED. THE HYPOTUBE WAS COMPLETELY SEPARATED 52.7CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED AND TORN, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE ARE NUMEROUS HYPOTUBE AND SHAFT KINKS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906159 ↗