NC TREK NEO™ 1400350-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08717648232633), received between Nov 22, 2022 and Sep 25, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Rupture; Difficult to Advance

  It was reported that the procedure was to treat a dde novo lesion in the proximal right coronary artery (pRCA) with 75% stenosis, moderate calcification and moderate tortuosity. The 3.5.x15mm NC TREK Neo balloon was advanced with resistance at the target lesion for predilation; however, the balloon ruptured during the initial inflation at 6 atm. The device was removed and the procedure continued using a non-Abbott balloon. 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 50900132 ↗
• MalfunctionApr 10, 2026Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED, BUT NOT SOAKED PRIOR TO USE. THE BALLOON CATHETER WAS THEN ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. ANOTHER NC TREK NEO BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845360 ↗
• MalfunctionMar 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 95% STENOSIS. THE 3.5X15 MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. ANOTHER 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 24640261 ↗
• MalfunctionDec 11, 2025Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING UNPACKING OF THE 3.50X15MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC), THE CATHETER [SHAFT] WAS KINKED. THERE WERE NO REPORTS OF A REPLACEMENT DEVICE USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THE GUIDEWIRE EXIT NOTCH WAS TORN DISTALLY FOR A LENGTH OF 10 MM. THE BDC BALLOON INFLATED AND DID NOT HOLD PRESSURE AND FLUID WAS OBSERVED LEAKING FROM THE GUIDE WIRE INFLATION LUMEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23781343 ↗
• MalfunctionNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS MODERATE RIGHT CORONARY ARTERY THAT IS 75% STENOSED. THE 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE INFLATED; HOWEVER, RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT BALLOON 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 23661620 ↗
• MalfunctionAug 21, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT AND ONCE AT THE LESION THE BDC RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. THE BDC WAS REMOVED AND ANOTHER NC TREK BALLOON WAS USED TO CONTINUE 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 22865199 ↗
• MalfunctionJan 22, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON USED FOR PRE-DILATATION BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 8 ATMOSPHERES. A NEW NC TREK BDC 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 21211864 ↗
• MalfunctionJan 8, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.50X15MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION WITH RESISTANCE NOTED DUE TO THE IMPLANTED STENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. 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 21102340 ↗
• MalfunctionDec 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE THE PROCEDURE WAS PERFORMED TO A TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION THROUGH RESISTANCE AND WAS ATTEMPTED TO BE INFLATED; HOWEVER, DURING THE SECOND INFLATION TO 12ATM THE BALLOON WAS NOTED TO RUPTURE. THE BDC WAS REMOVED AND ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 20879635 ↗
• MalfunctionDec 2, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 3.50X15MM 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 FIRST INFLATION AT 10 ATMOSPHERES. 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 20825061 ↗
• MalfunctionJun 17, 2024Leak/Splash; Difficult to Advance; Material Split, Cut or Torn; Leak/Splash; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE IN THE LEFT CIRCUMFLEX WITH MILD CALCIFICATION. THE 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS SUCCESSFULLY USED THE FIRST TIME. HOWEVER, THE SECOND TIME THE BDC WAS ADVANCED BACK INTO THE NON-ABBOTT 0.014 190CM GUIDEWIRE, A HOLE IN THE TRANSITION WAS NOTED AND BLEED BACK WAS COMING BACK THROUGH THE BDC. THERE WAS RESISTANCE FELT ADVANCING BACK INTO THE GUIDE WIRE. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE 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 19554537 ↗
• MalfunctionMay 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS PRE-DILATED AND A 3.5X48 MM DRUG ELUTING STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH THE 3.5X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) HOWEVER THE BALLOON RUPTURED AT 12 ATMOSPHERES AFTER 2 INFLATIONS. THE DEVICE WAS REMOVED AND ANOTHER UNSPECIFIED NC 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 19427965 ↗
• MalfunctionMar 8, 2024Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS NOT ABLE TO CROSS THE LESION. ONCE REMOVED FROM THE ANATOMY, IT WAS NOTED THE TIP WAS TORN. THE PROCEDURE WAS COMPLETED USING A NEW TREK CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864777 ↗
• MalfunctionFeb 22, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION. THE 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM) AFTER 10 SECONDS. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED FOLLOWED BY STENT IMPLANTATION 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 18763569 ↗
• MalfunctionFeb 7, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) IT WAS NOTED THE BALLOON WAS LEAKING. ANOTHER NC TREK NEO WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657868 ↗
• 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. THEREFORE, 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. 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 18619718 ↗
• MalfunctionJan 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH 90% STENOSIS, HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.5X15MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE BDC HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED TWICE BOTH AT 18 ATMOSPHERES (ATMS) FOR 15 SECONDS BUT RUPTURED DURING THE SECOND INFLATION. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER SAME SIZE NC TREK NEO BALLOON WAS USED TO COMPLETE 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 18510808 ↗
• MalfunctionDec 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PLCX) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEN, A 2.5X15MM NC TREK NEO BALLOON WAS INFLATED AT THE LESION; HOWEVER, THE BALLOON ALSO RUPTURED AT 6 ATM AFTER 5 SECONDS. THE NC TREK NEO BALLOON WAS REPLACED WITH A 3.5X15MM NC TREK NEO BALLOON, WHICH ALSO RUPTURED AT 11 ATM AFTER 5 SECONDS DURING THE FIRST INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ROTABLATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307461 ↗
• MalfunctionNov 29, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. THE NC TREK NEO RX 3.50 X 15MM BALLOON WAS ADVANCED WITH RESISTANCE FOR POST-DILATATION AFTER THE SAME-SIZED STENT DEPLOYMENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 10 ATMOSPHERES. A SAME SIZED NON-ABBOTT BALLOON WAS USED TO CONTINUE 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 18232585 ↗
• MalfunctionJul 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED FOR 5 SECONDS TO 10 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT AND A NEW SAME SIZE TREK 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 17415336 ↗
• MalfunctionJul 25, 2023Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) CORONARY ARTERY WITH MILD CALCIFICATION AND NONE TORTUOSITY. THE PROTECTIVE SHEATH OF THE 3.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS DIFFICULT TO REMOVE AND THE CONTRAST MIX WAS 50% SALINE, 50% CONTRAST. THE BALLOON WAS INFLATED ONCE AT 6 ATMOSPHERES FOR 15 SECONDS; HOWEVER, A SLOW INFLATION WAS NOTED; THEREFORE, BEFORE THE SECOND INFLATION THE STOPCOCK AND THE SYRINGE WERE REPLACED. ON THE SECOND INFLATION THE BALLOON WAS INFLATED AT 8 ATMOSPHERES FOR 15 SECONDS BUT THE INFLATION PROBLEM PERSISTED; HOWEVER, THE INFLATION WAS COMPLETED. AFTER 15 SECONDS ON NEGATIVE HELD, THE BALLOON WAS REMOVED COMPLETELY DEFLATED. THE BALLOON WAS REPLACED WITH ANOTHER NON-ABBOTT BALLOON TO COMPLETE THE PROCEDURE AND TWO NON-ABBOTT STENTS WERE IMPLANTED. 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 17390399 ↗
• MalfunctionJul 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE 3.5X15MM NC TREK NEO BALLOON WAS INFLATED, BUT RUPTURED AT 9 ATMOSPHERES DURING THE FIRST INFLATION. A SAME SIZE NON-ABBOTT BALLOON WAS USED FOR THE REPLACEMENT 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 17280493 ↗
• MalfunctionJun 30, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WITH THE LESION WAS MET DURING ADVANCEMENT. THE BDC WAS INFLATED ONCE AND A RUPTURE OCCURRED AT 8 ATMOSPHERES. THE BALLOON WAS REMOVED INDEPENDENTLY. ANOTHER 3.50X15MM TREK 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 17243055 ↗
• MalfunctionMay 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. AFTER THE STENT WAS IMPLANTED THE 3.50X12MM NC TREK NEO WAS USED ONCE AT 10 ATMOSPHERES (ATM) FOR POST DILATATE THE LESION WHEN A RUPTURE OCCURRED AT 10 ATM WHILE PRESSURE WAS INCREASED. AN UNSPECIFIED DEVICE 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 16872439 ↗
• MalfunctionMar 15, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID-RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. THE 3.5X15MM NC TREK NEO WAS ADVANCED TO THE LESION AND INFLATED TWICE TO 12 ATMOSPHERES. NEGATIVE WAS HELD FOR ABOUT 20 SECONDS AND THE BALLOON SLOWLY DEFLATED, BUT FAILED TO COMPLETELY DEFLATE. THE DEVICE WAS REMOVED WITHOUT ISSUE, PARTIALLY INFLATED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW NC TREK NEO WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550748 ↗