NC Quantum Apex™ H7493912420300Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729783480), received between Jun 16, 2017 and Jun 25, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED AT FRACTION OF SECOND. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605441 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, WHEN THE DEVICE WAS ADVANCED TO THE GUIDE CATHETER, THE SHAFT GOT FRACTURED OUTSIDE OF THE BODY BEFORE REACHING THE PATIENT'S CORONARY. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15186139 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DESCENDING ARTERY. DURING THE PROCEDURE, TWO 20MM X 2.50MM AND A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETERS WERE USED TO DILATE THE LESION. HOWEVER, DURING INFLATION AT LESS THAN 14 ATMOSPHERES, THE BALLOONS RUPTURED. THE DEVICES WERE REMOVED AND UPON CHECKING THE ARTERY, THE LESION WAS NOT DILATED. A ROTATIONAL ATHERECTOMY WITH A 1.75MM BALLOON WAS USED TO PREPARE THE ARTERY FOR STENT IMPLANTATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699670 ↗
• MalfunctionFeb 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION OF THE TARGET LESION. HOWEVER, DURING INFLATION, WITHOUT EXCEEDING THE MAXIMUM RUPTURE PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588784 ↗
• MalfunctionFeb 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST WITHOUT EXCEEDING THE MAXIMUM RUPTURE PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579842 ↗
• MalfunctionDec 17, 2021Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THE BALLOON FROZE ON THE WIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NONE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 20MM X 3.00MM NC QUANTUM APEX WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE PHYSICIAN PREPARED THE BALLOON AS NORMAL, PLACED THE BALLOON OVER THE WIRE NORMALLY FROM THE BALLOON TIP UNTIL THE END OF THE OVER-THE-WIRE (OTW) PART OF THE SHAFT. IT WAS EASY TO PUSH THE BALLOON THROUGH THE GUIDING CATHETER. SUDDENLY, WHEN REACHING THE LEFT MAIN, THE PHYSICIAN FELT A STRANGE RESISTANCE. DURING REMOVAL, IT WAS NOTED THAT IT WAS NOT POSSIBLE TO WITHDRAW THE BALLOON WITHOUT THE WIRE. THE WIRE WAS NOT IN THE TRUE LUMEN OF THE SHAFT ANYMORE. THE WIRE PASSED INTO THE LUMEN DISTAL TO THE BALLOON. THE DEVICES WERE STUCK TOGETHER. THE BALLOON WAS REMOVED WITH THE GUIDEWIRE BY WITHDRAW IN THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 20MM X 3.00MM NC QUANTUM APEX. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STABLE WITHOUT ANY IMPACT. THE WIRE WAS USED A NON-BOSTON SCIENTIFIC WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024847 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE HYPOTUBE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9482795 ↗
• MalfunctionSep 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BALLOON KINKED AND BROKE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8970823 ↗
• MalfunctionOct 30, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS CIRCUMFLEX ARTERY. AFTER ADVANCING A 8 FR JR4 NON-BSC GUIDE CATHETER AND CROSSING A SAMURAI GUIDE WIRE, A 3.0X20MM NC QUANTUM BALLOON CATHETER WAS SELECTED FOR USE. BEFORE INTRODUCING THE DEVICE, THE PHYSICIAN BENT THE SHAFT; HOWEVER, THE SHAFT SNAPPED AT APPROXIMATELY 24CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8019981 ↗
• MalfunctionOct 23, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. A 20MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE PACKAGE THAT CAME STRAIGHT FROM THE BOX AND THE INNER PACKAGE WAS NOT SEALED. THE DEVICE WAS NOT USED INSIDE THE PATIENT. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7995970 ↗
• MalfunctionJun 16, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. AFTER PLACING A STENT, A 20MM X 3.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER UPON TAKING THE BALLOON DOWN, THE BALLOON FAILED TO DEFLATE. AFTER QUITE A WHILE OF WORKING WITH THE BALLOON, THE DEVICE WAS EVENTUALLY REMOVED IN A SEMI-DEFLATED STATE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648221 ↗