NC TREK NEO™ 1400300-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08717648232510), received between Apr 4, 2023 and Apr 9, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (35 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.0X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 18 ATMOSPHERES. ANOTHER SAME SIZE NC TREK NEO BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834456 ↗
• MalfunctionMar 11, 2026Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY. THE 3.00X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED; HOWEVER, THE BALLOON APPEARED TO NOT EXPAND PROPERLY. THE BDC WAS REMOVED, AND A NEW NC 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 24571214 ↗
• MalfunctionMar 3, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE 3.0X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE TO 12 ATMOSPHERES AND RUPTURED. 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 24495608 ↗
• MalfunctionFeb 27, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. THE 3.0 X 12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR POST DILATATION AND RESISTANCE WAS NOTED WITH THE STENT. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES AND RUPTURED. A NEW NC TREK 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 24471765 ↗
• MalfunctionJan 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED RIGHT CORONARY ARTERY. AN NC TREK 3.0X12MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 8ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH A NON-ABBOTT DEVICE. 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 23944192 ↗
• MalfunctionNov 20, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.0X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS DIFFICULT TO CROSS THE LESION DUE TO THE ANATOMY, BUT EVENTUALLY CROSSED. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND RUPTURED. A NEW SAME SIZE NC TREK NEO 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 23610231 ↗
• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 90% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. DILATION WAS THEN PERFORMED USING A WOLVERINE 2.75X10MM. SUBSEQUENTLY, A 3.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED WITH NO RESISTANCE FELT DURING DELIVERY, HOWEVER, UPON THE FIRST INFLATION TO APPROXIMATELY 6 ATMOSPHERES, A RUPTURE WAS OBSERVED. IT IS BELIEVED THAT THE RUPTURE MAY HAVE BEEN CAUSED BY CONTACT WITH RESIDUAL NODULAR CALCIFICATION. THE DEVICE WAS REPLACED WITH A TASUKI 3.0X10MM, AND A 3.0X15MM XIENCE SKYPOINT STENT. 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 23598617 ↗
• MalfunctionNov 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATED TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA)LESION WITH 90% STENOSIS. THE 3.00 X 12MM NC NEO TREK BALLOON DILATATION CATHETER WAS ADVANCED FOR PRE-DILATION. RESISTANCE WAS NOTED WITH THE ANATOMY AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THE TREK WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TREK BALLOON. 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 23456647 ↗
• MalfunctionAug 22, 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 MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BALLOON WAS REMOVED FROM THE PATIENT. 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 22877867 ↗
• MalfunctionJul 15, 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 RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 3.00X12MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE NC TREK BALLOON RUPTURED AT 8 ATMOSPHERES ON THE SECOND INFLATION. THE NC TREK NEO BDC WAS REMOVED AND 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 22511885 ↗
• MalfunctionJul 10, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TWICE TO 8 ATMOSPHERES BUT RUPTURED. AN UNSPECIFIED 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 22472609 ↗
• MalfunctionJul 10, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 3.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 22467366 ↗
• MalfunctionJun 16, 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 DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 22213856 ↗
• MalfunctionMay 20, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FELT WITH ANATOMY. ONCE AT THE LESION DURING THE FIRST INFLATION THE BDC RUPTURED AT 6 ATMOSPHERES. THE BALLOON WAS REMOVED. A NEW TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 22055543 ↗
• MalfunctionMay 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TWICE TO 8 ATMOSPHERES AND RUPTURED. A NEW NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 22047621 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. A NON-ABBOTT STENT WAS PLACED AND A 3.0X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED FOR POST DILATATION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. ANOTHER NC TREK NEO 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 22034906 ↗
• MalfunctionApr 25, 2025Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE HUB OF THE 3.0X12MM NC TREK BALLOON DILATATION CATHETER PRINTED INFORMATION IS DIFFICULT TO SEE. THERE WAS 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 21911217 ↗
• MalfunctionMar 14, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.0X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE DEVICE WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED THREE TIMES TO 8 ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED AND A NEW TREK BDC 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 21608715 ↗
• MalfunctionJan 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF A 3.00X12MM NC TREK NEO BALLOON DILATATION CATHETER WITH ANATOMY. THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 21057622 ↗
• MalfunctionNov 18, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THERE WAS RESISTANCE FELT DURING ADVANCEMENT OF THE 3.0X12MM NC TREK NEO BALLOON DILATATION CATHETER WITH ANATOMY. ONCE AT THE LESION DURING THE FIRST INFLATION AT 10 ATMOSPHERES THE BALLOON RUPTURED. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE 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 20707979 ↗
• MalfunctionNov 4, 2024Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE HUB OF THE 3.0X12MM NC TREK BALLOON DILATATION CATHETER PRINTED INFORMATION IS DIFFICULT TO SEE. THERE WAS 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 20599886 ↗
• MalfunctionOct 16, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST DIAGONAL CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. FOR PRE-DILATION, THE 3.0×12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE IFU AND ADVANCED WITH RESISTANCE FELT FROM THE PATIENTS ANATOMY. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES WHEN A RUPTURE OCCURRED. ANOTHER 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 20467663 ↗
• MalfunctionSep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. A NON- ABBOTT STENT WAS DEPLOYED; HOWEVER, DUE TO CALCIFICATION, THE NON- ABBOTT STENT WAS NOT FULLY APPOSED. THEREFORE, THE 3.0X12 MM NC TREK BALLOON WAS USED FOR POST-DILATION. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES (ATM) FOR 15 SECONDS, THEN INFLATED A SECOND TIME WHEN A RUPTURE OCCURRED AT AN UNKNOWN PRESSURE. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE STENT WAS ALMOST DILATED AND A NON-ABBOTT 3.0X12MM BALLOON DILATATION CATHETER WAS INFLATED TO 18 ATM TO FINISH 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 20306123 ↗
• MalfunctionSep 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT CIRCUMFLEX CAROTID ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.0X12MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS ADVANCED WITH RESISTANCE DUE TO THE PATIENT'S ANATOMY. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES WHEN A RUPTURE OCCURRED. ANOTHER 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 20158030 ↗
• MalfunctionJul 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. AFTER DEPLOYMENT OF A NON-ABBOTT STENT, THE 3X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION. DURING THE FIRST INFLATION THE BALLOON OF THE BDC RUPTURED AT 14 ATMOSPHERES; THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED IN 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 19843638 ↗