NC TREK NEO™ 1400350-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08717648232626), received between Feb 21, 2023 and May 19, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT DEVICE PREPARATION OF THE 3.5X12 MM NC TREK NEO WAS PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AND NO ISSUES WERE ENCOUNTERED. FOR PREDILATATION, THE NC TREK NEO BALLOON WAS ADVANCED TO THE MODERATELY CALCIFIED AND TORTUOUS, RIGHT CORONARY ARTERY. RESISTANCE WAS ENCOUNTERED WITH THE LESION SITE DURING ADVANCEMENT TO THE TARGET LESION. THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 3 ATMOSPHERES. AS A RESULT, THE NC TREK NEO WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING ANOTHER NC TREK BALLOON. THERE WERE NO PATIENT ADVERSE EVENTS, AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAYS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218915 ↗
• MalfunctionMay 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.5X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. A NON-ABBOTT BALLOON 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 25141796 ↗
• MalfunctionApr 27, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.5X12 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 6 ATMOSPHERES. ANOTHER NC TREK BALLOON 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 24999845 ↗
• MalfunctionDec 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 3.50X12MM NC TREK NEO RX BALLOON DILATATION CATHETER, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. 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 23929344 ↗
• MalfunctionNov 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING ARTERY (LAD)LESION. A 3.50 X 12MM NC TREK NEO RX BDC WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE, WITH NO ISSUES ENCOUNTERED. THE BDC WAS ADVANCED WITH RESISTANCE FELT WITH THE ANATOMY TO THE TARGET LESION FOR PRE-DILATION. HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES. AS A RESULT, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 23526312 ↗
• MalfunctionMay 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 AND HEAVY TORTUOSITY. THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. A NEW NC 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 22022451 ↗
• MalfunctionMay 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, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3.5X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY AND THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED AND A NEW NC TREK NEO 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 22020987 ↗
• MalfunctionMay 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). AFTER A 3.25X12MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION, THE BDC WAS ATTEMPTED TO BE INFLATED; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE, THE BDC WAS REPLACED WITH A 3.50X12MM NC TREK NEO BDC; HOWEVER, AFTER THE BDC WAS PREPARED AND ADVANCED TO THE LESION, THE BALLOON WAS NOTED TO RUPTURE AT 6 ATMS DURING THE FIRST INFLATION. AT THIS POINT, THE BDC WAS REMOVED AND THE VESSEL WAS PRE-TREATED WITH A ROTATIONAL ATHERECTOMY (ROTA) DEVICE TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996147 ↗
• InjuryMay 6, 2025Entrapment of Device; Material Separation; Difficult to Advance; Entrapment of Device; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING THE DEPLOYMENT OF TWO NON-ABBOTT STENTS, A 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, USING THE KISSING METHOD, THROUGH RESISTANCE AND USED TO POST-DILATE THE TWO NON-ABBOTT STENTS. HOWEVER, FOLLOWING POST-DILATATION TO NOMINAL PRESSURE SIX TIMES, THE BDC WAS COMPLETELY DEFLATED; HOWEVER, RESISTANCE WAS FELT DURING WITHDRAWAL AND THE HYPOTUBE OF THE BDC WAS NOTED TO SEPARATE. AT THIS TIME AN ATTEMPT TO REMOVE THE SEPARATED HYPOTUBE WAS MADE USING A SNARE AND A NON-ABBOTT BDC; HOWEVER, THE NON-ABBOTT BDC WAS ALSO NOTED TO SEPARATE. THEREFORE, THE PATIENT WAS SENT TO UNDERGO SURGERY TO SURGICALLY REMOVE THE 2 SEPARATED BDC'S. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED; HOWEVER, THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968327 ↗
• MalfunctionApr 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THE 3.50X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED INTO THE GUIDING CATHETER HOWEVER THE PROXIMAL SHAFT SEPARATED. THE DISTAL PORTION OF THE SEPARATED DEVICE WAS SIMPLY WITHDRAWN FROM THE GUIDING 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 21772649 ↗
• MalfunctionJan 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED, WITH NO NOTED ISSUES, IT WAS ADVANCED TO THE LESION, THROUGH RESISTANCE, AND ATTEMPTED TO BE USED FOR VESSEL DILATATION. HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 18ATM. THE BDC WAS REPLACED WITH A SAME SIZED NC TREK AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275250 ↗
• MalfunctionJan 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STYLET OF THE 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS NOT ABLE TO BE REMOVED FROM THE BDC; THEREFORE, THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191472 ↗
• MalfunctionJan 6, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS ANTERIOR DESCENDING CORONARY ARTERY. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 3.50X12MM NC TREK NEO BALLOON IN AN UNSPECIFIED GUIDING CATHETER AND GOT STUCK. RESISTANCE WAS ALSO NOTED DURING REMOVAL OF THE NC TREK BALLOON IN THE GUIDING CATHETER. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081077 ↗
• MalfunctionDec 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 3.50X12MM 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 18 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 20879298 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.5×12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE AND ADVANCED FOR PRE-DILATION. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES FOR 5 SECONDS WHEN A RUPTURE OCCURRED. ROTATIONAL ATHERECTOMY WAS THEN PERFORMED. A NEW 3.5X12 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 19799843 ↗
• MalfunctionMay 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE AS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT IS 75% STENOSED. THE 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THE DEVICE WAS CHECKED OUTSIDE THE ANATOMY, IT WAS UNABLE TO APPLY PRESSURE WITH INDEFLATOR. ANOTHER BALLOON WAS USED TO SUCCESSFULLY 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 19232911 ↗
• MalfunctionFeb 14, 2024Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5X12MM NC TREK NEO BALLOON DILATION CATHETER (BDC) THE HUB WAS NOTED TO NOT BE ABLE TO CONNECT PROPERLY TO AN INDEFLATOR DURING AIR PREP. THE BDC WOULD NOT HOLD NEGATIVE AND THE DEVICE WAS NOTED TO BE PULLING AIR. THEREFORE, THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708213 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.50 X 12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION, BUT A BALLOON RUPTURE OCCURRED DURING THE FIRST INFLATION AT AN UNKNOWN PRESSURE. A NON-ABBOTT BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18448940 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND USED FOR POST DILATION. THE BDC WAS INFLATED ONCE TO 12 ATMOSPHERES AND RUPTURED DURING USE. ANOTHER 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 18446366 ↗
• MalfunctionDec 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE 90% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 3.50X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 12 ATMOSPHERES DURING THE FIRST INFLATION; HOWEVER, RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 20 SECONDS. ANOTHER 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 18301358 ↗
• MalfunctionDec 7, 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 90% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPPED (AIR ASPIRATION) INSIDE THE PATIENT PRIOR TO USE. THE BDC WAS USED FOR POST-DILATATION OF A NON-ABBOTT STENT; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES AFTER 10 SECONDS DURING THE FIRST INFLATION. 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 18288313 ↗
• MalfunctionNov 10, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.50X12MM NC TREK NEO BALLOON CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO ISSUE; HOWEVER, FOLLOWING SUCCESSFUL INFLATION AND DEFLATION IT BECAME STUCK WITH A .014 GUIDE WIRE DURING REMOVAL AND COULD NOT BE REMOVED INDEPENDENTLY. THE BDC AND THE .014 GUIDE WIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. 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 18112777 ↗
• MalfunctionSep 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. THE NC TREK NEO RX 3.50 X 12MM BALLOON RUPTURED DURING THE SECOND INFLATION TO 12 ATMOSPHERES. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. A 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 17804397 ↗
• MalfunctionJul 25, 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 90% DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. AFTER DEPLOYMENT OF A 3.5MM NON-ABBOTT STENT, THE 3.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. THE BALLOON RUPTURED DURING THE FIRST INFLATION FOR 10 SECONDS AT 12 ATMOSPHERES. THE BDC WAS REMOVED AND A NON-ABBOTT NON-COMPLIANT BALLOON WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TREK NEO BDC WAS AIR ASPIRATED/PREPPED INSIDE OF THE ANATOMY. 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 17392809 ↗
• MalfunctionJul 21, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. A 3.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT COULD NOT CROSS THE DIFFICULT ANATOMY. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374446 ↗