NC Quantum Apex™ H7493912412250Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729783244), received between Dec 3, 2018 and Mar 4, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 12 X 2.50 MM NC QUANTUM APEX MR BALLOON CATHETER WAS SELECTED FOR USE. WHILE A WIRE WAS BEING ADVANCED THROUGH THE BALLOON, A HOLE BETWEEN THE IN AND EXIT PORT WAS OBSERVED, THROUGH WHICH THE GUIDEWIRE WAS EXITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506115 ↗
• MalfunctionOct 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED WITH A 12MM X 2.50MM NC QUANTUM APEX? BALLOON CATHETER. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 15 MM NC QUANTUM APEX BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387944 ↗
• MalfunctionApr 5, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER, IT WAS FOUND THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NC QUANTUM APEX BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055566 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON OPENING, IT WAS NOTED THAT THE SHAFT WAS DAMAGED AND SEPARATED INTO TWO PIECES WITHIN ITS JACKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460085 ↗
• InjuryApr 25, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUES OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX AND A 4.00 X 32MM SYNERGY XD WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE STENT WAS SUCCESSFULLY DELIVERED AND EXPANDED, IT WAS NOTED THAT THE BALLOON GOT STUCK IN THE GUIDE. ANOTHER INFLATION DEVICE WAS USED IN AN ATTEMPT TO FULLY DEFLATE THE BALLOON, BUT IT REMAINED STUCK IN THE GUIDE, SO A WIRE WAS USED TO POP AND FURTHER DEFLATE THE BALLOON. NEXT THE NC BALLOON GOT STUCK IN THE GUIDE AFTER DEFLATION AND THE NC BALLOON WAS ALSO POPPED TO FURTHER DEFLATE. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809383 ↗
• MalfunctionMar 31, 2023Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29MAR2023. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED, AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 2X12 SEMI COMPLIANT BALLOON. A 2.5 X 24MM SYNERGY STENT WAS IMPLANTED. FOLLOWING STENT IMPLANTATION, A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION, BUT THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED AND REPLACED WITH A 2.5 X 12MM NON-BSC BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659631 ↗
• MalfunctionSep 29, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS VESSEL. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER 7 INFLATIONS AT 26 ATMOSPHERES, THE BALLOON WAS DIFFICULT TO RETRACT OFF THE NON-BOSTON SCIENTIFIC GUIDEWIRE DUE TO SIGNIFICANT RESISTANCE. THE BALLOON WAS DEFLATED PRIOR TO REMOVAL ATTEMPT AND IT TOOK AN EFFORT TO REMOVE THE DEVICE. EVENTUALLY, THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505208 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT OF THE BALLOON BROKE WHILE ADVANCING INTO THE LESION. THE PHYSICIAN REMOVED THE WHOLE SYSTEM OUT AND AFTER THAT TOOK AN ALTERNATE ACCESS FOR COMPLETING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14323656 ↗
• MalfunctionMay 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED OBTUSE MARGINAL ARTERY. AN 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM) FOR 2 SECONDS, THE BALLOON RUPTURED. SUBSEQUENTLY, A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING THE FIRST INFLATION AT 8 ATM FOR 2 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT 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 14287901 ↗
• MalfunctionApr 1, 2022Inflation Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO BE INFLATED AND THE BALLOON WAS DAMAGED. THE 55% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NONE CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 12MM X 2.50MM NC QUANTUM APEX BALLOON WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING PROCEDURE, A NC QUANTUM APEX DEVICE WAS ADVANCED TO THE LESION SITE AND THE BALLOON FAILED TO INFLATE. WHEN THE BALLOON WAS REMOVED FROM THE PATIENT, THE BALLOON WAS DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NC QUANTUM APEX BALLOON DEVICE AND THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978384 ↗
• MalfunctionMay 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED, 22X2.75MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE BALLOON STARTS DEFLATING AFTER CROSSING NOMINAL PRESSURE. THE BALLOON WAS NOT INFLATING PROPERLY AND IT WAS NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868842 ↗
• MalfunctionMay 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED, 2.25MMX20MM, ECCENTRIC, DE NOVO TARGET LESION CONTAINING A =90 DEGREES BEND WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER THE LESION WAS ENGAGED WITH A 6F NON-BSC GUIDE CATHETER AND CROSSED WITH A NON-BSC GUIDEWIRE, PRE-DILATATION WAS PERFORMED WITH A 1.50X6 NON-BSC BALLOON CATHETER RESULTING TO 80% RESIDUAL STENOSIS. FOLLOWING PRE-DILATATION, A 2.25X23MM NON-BSC STENT WAS DEPLOYED AND A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838996 ↗
• MalfunctionMay 14, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-APR-2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. WHILE THE DEVICE WAS BEING ADVANCED IN THE LESION, THE SHAFT KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825453 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 12 MM X 2.50 MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR DILATATION. UPON OPENING THE PACKAGE IN A STERILE FASHION, IT WAS NOTICED THAT THE SHAFT OF THE BALLOON WAS COMPLETELY BROKEN APART. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THAT THE BREAK OCCURRED JUST PROXIMAL TO THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11007686 ↗
• MalfunctionMay 21, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE NC QUANTUM APEX WAS ADVANCED OVER AN UNKNOWN GUIDEWIRE. DURING REMOVAL, IT WAS NOTED THAT IT WAS NOT POSSIBLE TO WITHDRAW THE BALLOON WITHOUT THE WIRE. THE DEVICES WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10078707 ↗
• MalfunctionApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAR2020. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS RECEIVED WITH NO ISSUE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN CIRCUMFERENTIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978469 ↗
• MalfunctionMar 26, 2020Fracture; Fracture

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03/05/2020. IT WAS REPORTED THAT THE SHAFT WAS DAMAGED. A 12MM X 2.50MM NC QUANTUM APEX WAS SELECTED HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884870 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE BALLOON SHAFT BROKE. THE GUIDE WAS PULLED OUT WITH THE BALLOON SHAFT IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9416451 ↗
• MalfunctionSep 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PUNCTURE OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS OPENED FOR CORONARY ANGIOPLASTY. DURING THE PRESSURE-NEGATIVE PREPPING PROCEDURE WITH A SYRINGE GAUGE, AIR WAS COMING INTO THE SYRINGE AND A BALLOON PUNCTURE WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED AT THE TIME WHEN ASPIRATION WAS PERFORMED TO MAKE THE NEGATIVE PRESSURE, IT WAS NOTED THAT THERE WAS BLOOD IN THE SYRINGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. ONE TO TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090356 ↗
• MalfunctionSep 6, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-AUG-2019. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED A BEND MORE THAN OR EQUAL TO 90 DEGREES. A 12MM X 2.50MM NC QUANTUM APEX WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON DID NOT EXPAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON WITH A BUDDY WIRE SUPPORT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970824 ↗
• MalfunctionAug 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 30-JUL-2019. IT WAS REPORTED THAT DIFFICULTY LOADING A WIRE OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, A 12MM X 2.50MM NC QUANTUM APEX WAS USED BUT A NON-BSC GUIDEWIRE COULD NOT PASS THE DEVICE. WHILE ADVANCING THE WIRE SOME CENTIMETERS, THE WIRE BECAME STUCK AT THE ENTRY OF THE DEVICE (AT THE END OF THE BALLOON). THE EVENT WAS NOTED TO HAVE OCCURRED OUTSIDE THE PATIENT. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE IN THE OUTER SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912670 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INFLATION OF THE DEPLOYED 2.75 X 18MM NON-BSC STENT AT 20 ATMOSPHERES FOR 14 SECONDS, THE BALLOON RUPTURED. WHEN THE PHYSICIAN TRIED TO RETRIEVE THE BALLOON, THE PROXIMAL 37CM OF THE BALLOON HAD SEPARATED FROM THE BALLOON SHAFT. THE SEPARATED PROXIMAL 37CM OF THE BALLOON CATHETER WAS RETRIEVED FROM THE PATIENT'S BODY AND AT CLOSE INSPECTION, IT APPEARED THAT THE BALLOON DID NOT BURST. THE FAILURE WAS AT THE CONNECTION WHERE THE PROXIMAL 37CM MEETS THE REST OF THE BALLOON SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586992 ↗
• MalfunctionMar 20, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-FEB-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, 28X3MM, CONCENTRIC TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. THE LESION CONTAINED BETWEEN A 45 AND 95 DEGREE BEND. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436583 ↗
• MalfunctionDec 3, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-NOV-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TIGHT TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 12MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS COMPLETELY REMOVED AND 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 PINHOLE. RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MINOR KINKS ON THE HYPOTUBE AT 7.5CM, 16CM, AND 50CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED A PINHOLE IN THE BALLOON 7MM FROM THE TIP. THERE IS BLOOD PRESENT IN THE BALLOON AND THE BALLOON IS LOOSELY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126928 ↗