NC TREK NEO™ 1400450-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648232749), received between Apr 11, 2023 and May 26, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY #3 THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 4.50X8MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH THE LESION. ONCE AT THE LESION FOR PREDILATATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. A TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280168 ↗
• MalfunctionMar 5, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, AND 75% STENOSED LEFT CIRCUMFLEX ARTERY. AN NC TREK 4.50X8MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT HAD DIFFICULTIES CROSSING THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 8ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524524 ↗
• MalfunctionFeb 26, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. FOR POST-DILATATION, THE 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451154 ↗
• MalfunctionJan 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 4.50X8MM NC TREK NEO BALLOON DILATATION CATHETER, RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950345 ↗
• MalfunctionSep 5, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 4.5X8 NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED BEFORE USE. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984089 ↗
• MalfunctionAug 14, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING ADVANCEMENT OF A 4.50X8MM NC TREK NEO BALLOON DILATATION CATHETER, RESISTANCE WAS MET WITH ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809660 ↗
• MalfunctionAug 5, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER NC TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715084 ↗
• MalfunctionMay 13, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT CIRCUMFLEX (CX). A 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, AND ADVANCED TO THE LESION, THROUGH RESISTANCE, TO DILATE THE LESION; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATMS. THEREFORE, THE BDC WAS REMOVED AND REPLACED WITH A NEW NC TREK BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009890 ↗
• MalfunctionDec 13, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. AFTER A NON-ABBOTT GUIDEWIRE (GW) WAS ADVANCED TO THE TARGET LESION, A 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED ONTO THE NON-ABBOTT GW; HOWEVER, RESISTANCE WITH THE GW WAS NOTED AND THE BDC WAS REMOVED BEFORE ENTERING THE ANATOMY. DURING REMOVAL RESISTANCE WAS FELT AND THE TIP OF THE BDC WAS NOTED TO SEPARATE, AND WAS SIMPLY REMOVED. A SAME SIZED NC TREK NEO WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930499 ↗
• MalfunctionDec 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. PRE-DILATATION WAS PERFORMED WITH THE 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WHICH WAS PREPPED PER INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED WITH RESISTANCE FELT FROM THE ANATOMY. THE BALLOON WAS INFLATED ONCE THEN ON THE SECOND INFLATION AT 8 ATMOSPHERES A RUPTURE OCCURRED. ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859964 ↗
• MalfunctionNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5X8MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION TO POST DILATE THE PROXIMAL END OF THE XIENCE SKYPOINT STENT; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800704 ↗
• MalfunctionNov 25, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. THE 4.5 X 8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT; HOWEVER, ONCE AT THE LESION THE BDC WAS INFLATED. AT THE SECOND INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. ANOTHER NC TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772655 ↗
• MalfunctionApr 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. A STENT WAS IMPLANTED AND POST DILATION WAS PERFORMED WITH A 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WHICH WAS PREPPED PER INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE BALLOON WAS INFLATED ONCE TO 4 ATMOSPHERES AND RUPTURED. A 5.0X8 NC TREK NEO BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154511 ↗
• MalfunctionApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE NC TREK NEO RX 4.50 X 8MM WAS USED TO PERFORM POST-DILATION. IT WAS INFLATED TO 12 ATMOSPHERES, BUT RUPTURED DURING THE FIRST INFLATION. A SAME SIZE NC TREK NEO WAS USED. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075621 ↗
• MalfunctionJan 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RESTENOSIS IN A 90% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH MODERATE CALCIFICATION. THE 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) AFTER 5 SECONDS. THE BDC WAS REMOVED FROM THE PATIENT AND A 3.5X15MM NC TREK BDC WAS ATTEMPTED TO BE USED IN THE PROCEDURE, BUT THE 3.5X15MM BALLOON ALSO RUPTURED AT 14 ATM AFTER 5 SECONDS. THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619720 ↗
• MalfunctionDec 15, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE PERFORMED FOR THE IN-STENT RESTENOSIS IN THE RIGHT CORONARY ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION, THERE WAS RESISTANCE WITH THE LESION DURING ADVANCEMENT OF THE NC TREK NEO RX 4.50 X 8 MM BALLOON DILATATION CATHETER. THE BALLOON RUPTURED AT AROUND 10 ATMOSPHERES DURING INFLATION. THE BALLOON WAS REMOVED AND THE RUPTURE WAS NOTED IN THE PROXIMAL PART OF THE BALLOON. IT IS CONSIDERED THAT THE BALLOON RUPTURED IN THE CALCIFIED PART. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340486 ↗
• MalfunctionNov 20, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED MID RIGHT CORONARY ARTERY (RCA). A 4.50X8MM NC TREK NEO BALLOON CATHETER (BDC) WAS USED FOR POST DILATATION OF A NON ABBOTT STENT; HOWEVER, THERE WAS RESISTANCE FELT WITH THE LESION DURING ADVANCEMENT AND A BALLOON RUPTURE OCCURRED AFTER THE FIRST INFLATION AT 12 ATMOSPHERES. THEREFORE, A NON-ABBOTT BALLOON CATHETER (BDC) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175259 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 4.50X8MM NC TREK NEO BALLOON DILATATION CATHETER WAS USED FOR PRE-DILATATION, BUT RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES AFTER 10 SECONDS INFLATION. A SAME-SIZED NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961219 ↗
• MalfunctionSep 5, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT MAIN ARTERY (LM) TO MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION. THE 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE PRIOR TO USE BUT WAS PREPARED (AIR ASPIRATION) INSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATMS). THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684086 ↗
• MalfunctionJul 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH 90% STENOSIS, NO CALCIFICATION AND NO TORTUOSITY. A 4.0X12MM NON-ABBOTT STENT WAS IMPLANTED. THE 4.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE BDC DID NOT GET CAUGHT IN THE IMPLANTED STENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION OF UP TO 12 ATMOSPHERES (ATMS). THERE WAS NO RESISTANCE DURING REMOVAL. A SAME SIZE NON-ABBOTT BALLOON WAS USED FOR POST DILATATION AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426046 ↗
• MalfunctionApr 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN LEFT MAIN TRUNK ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 4.50X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AFTER 10 SECONDS AT 18 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. PRIOR TO USE, THE CATHETER WAS SOAKED IN SALINE. THE DEVICE WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN PROTECT SHEATH WAS REMOVED. A 4.00X8MM NC TREK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717114 ↗