NC TREK NEO™ 1400250-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648232411), received between Mar 16, 2023 and May 11, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (23 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY LESION WITH 90% STENOSIS. A 2.50X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION. HOWEVER, RESISTANCE WAS NOTED DURING ADVANCEMENT TO THE LESION. DURING THE FIRST INFLATION AT 12 ATM, THE BALLOON RUPTURED. AN ADDITIONAL NC TREK NEO 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 25139484 ↗
• MalfunctionFeb 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH SLIGHT RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 4 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 24389685 ↗
• MalfunctionDec 11, 2025Material 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 LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X15MM 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 6 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 23777159 ↗
• MalfunctionNov 20, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE 2.50X15MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE INITIAL INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER 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 23606187 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 75% STENOSED. THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE 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 23577366 ↗
• MalfunctionNov 3, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE 2.50 X 15MM NC TREK NEO RX WAS TO BE USED IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH RESISTANCE BETWEEN THE BALLOON AND THE LESION. HOWEVER, THE NC TREK RUPTURED AT 11 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE NC TREK WAS REMOVED AND ANOTHER 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 23458069 ↗
• MalfunctionNov 3, 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, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 2.50X15MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS FELT DUE TO ANATOMY. ONCE AT THE LESION DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE NC TREK NEO RX 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 23457626 ↗
• MalfunctionAug 29, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS INITIALLY CROSSED AN UNKNOWN GUIDEWIRE (GW), AND PRE-DILATED WITH A 1.5X12MM NON- ABBOTT BALLOON DILATATION CATHETER (BDC); HOWEVER, A PINHOLE RUPTURE WAS NOTED AT 8ATMS. FOLLOWING THIS, A 2.5X15MM NC TREK BDC WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE WITH THE ANATOMY, BUT DURING THE INITIAL INFLATION A BALLOON RUPTURE WAS NOTED AT 6ATMS. THEREFORE, THE BDC WAS REPLACED WITH A NON-ABBOTT BDC AND FOLLOWING ORBITAL ATHERECTOMY THE PROCEDURE WAS COMPLETED WITH A 2.75X18MM STENT. 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 22925815 ↗
• MalfunctionAug 25, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. DURING USE WITH THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), IT WAS NOTED THAT ONLY 1 RADIOPAQUE MARKER WAS VISIBLE; THEREFORE, IT WAS UNABLE TO BE SIZED. THE BDC WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITH THE USE OF ANOTHER BDC. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885640 ↗
• MalfunctionJul 15, 2025Peeled/Delaminated; Failure to Advance; Material Split, Cut or Torn; Peeled/Delaminated; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.5X15MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED INTO THE LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. FOLLOWING SEVERAL FAILED ATTEMPTS TO CROSS WITH THE BDC, THE BDC WAS REMOVED AND IT WAS NOTED THAT BALLOON HAD PEELED BACK AND TORN. A 2.0X15MM AND A 2.5X13MM NON-ABBOTT BALLOON WERE USED AND THE LESION WAS TREATED WITH A 3.0X48MM XIENCE SKYPOINT DRUG ELUTING STENT (DES), COMPLETING THE PROCEDURE. 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 22511332 ↗
• InjuryApr 28, 2025Deflation Problem; Difficult to Remove; Material Separation; Device Damaged by Another Device; Deflation Problem; Difficult to Remove; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL LEFT MAIN (LM), LEFT ANTERIOR DESCENDING ARTERY AND THE CIRCUMFLEX ARTERY THAT IS HEAVILY CALCIFIED. THE 2.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WOULD NOT FULLY DEFLATE NOTED BY THE IMAGES PROVIDED. WHEN ATTEMPTING TO REMOVE THE BDC THROUGH THE GUIDING CATHETER RESISTANCE WAS MET WITH A PREVIOUSLY IMPLANTED STENT. THE BDC BECAME STUCK AND SEPARATED. THE PREVIOUSLY IMPLANTED STENT AND STUCK BDC HAD TO WERE REMOVED TOGETHER. THE SEPARATED PORTION OF THE BDC WAS SNARED OUT WITH THE ENTIRE SYSTEM AS THE SNARE DEVICE BECAME STUCK IN THE RADIAL SHEATH. THE LESION WAS RE-STENTED WITH NEW UNSPECIFIED STENTS, UNSPECIFIED BALLOON, UNSPECIFIED WIRES AND UNSPECIFIED GUIDING CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921287 ↗
• MalfunctionFeb 21, 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 LEFT ANTERIOR DESCENDING (MLAD) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM 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 RUPTURED OCCURRED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DEBULKING AND A NON-ABBOTT BALLOON. 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 21437074 ↗
• MalfunctionJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). A 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATION; HOWEVER THE BALLOON WAS NOTED TO RUPTURE DURING THE FIRST INFLATION AT 6 ATM. THE RUPTURED BDC WAS REPLACED WITH A NEW TREK BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053917 ↗
• MalfunctionDec 9, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND FIRST DIAGONAL ARTERIES. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON, THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE BIFURCATION OF THE LAD; THEN THE NON-ABBOTT BALLOON WAS REMOVED. A 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS THEN ATTEMPTED TO BE ADVANCE TO THE FIRST DIAGONAL; HOWEVER, THE SDS BECAME STUCK IN THE GUIDE CATHETER. THEREFORE, THE GUIDE WIRE, SDS AND BDC WERE REMOVED WITH RESISTANCE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886267 ↗
• MalfunctionOct 18, 2024Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED. THE BDC BECAME STUCK WITH THE WIRE AND THE TIP OF THE BALLOON BECAME TORN. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20485285 ↗
• MalfunctionAug 21, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 2.5 X 15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE. THE BALLOON WAS ADVANCED AND FELT RESISTANCE WITH THE LESION SITE. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES WHEN A RUPTURE OCCURRED. A NON-ABBOTT BDC 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 20020234 ↗
• MalfunctionAug 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917156 ↗
• MalfunctionJun 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THE 2.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TWICE TO 15 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. DEBULKING WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505166 ↗
• MalfunctionMar 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE SECOND DIAGONAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR POST-DILATATION, THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING FIRST INFLATION. 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 18822204 ↗
• MalfunctionDec 22, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES AFTER 5 SECONDS; THEREFORE, THE BDC 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 18387776 ↗
• MalfunctionDec 18, 2023Material 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 MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES AFTER 5 SECONDS. THEREFORE, 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 18349434 ↗
• 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 18307460 ↗
• MalfunctionNov 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. AFTER AN UNSPECIFIED STENT WAS IMPLANTED, THE 2.5X15MM NC TREK NEO WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE SECOND DILATION FOR 10 SECONDS. A NEW SAME-SIZED NC TREK NEO 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 18062196 ↗
• MalfunctionJun 29, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS,90% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY. A 2.50X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY, AND THE BALLOON WAS INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE DELIVERY SYSTEM WITH THE RUPTURED BALLOON WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND A NEW TREK BDC 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 17233304 ↗
• MalfunctionJun 26, 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 MILDLY CALCIFIED AND TORTUOUS AND 75% STENOSED. THE 2.5X15MM NC TREK NEO BALLOON WAS DELIVERED TO THE LESION FOR PRE-DILATATION, BUT RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT BALLOON WAS USED FOR THE REPLACEMENT TO PERFORM PRE-DILATATION AND A NON-ABBOTT STENT WAS DEPLOYED. A NON-COMPLIANT BALLOON WAS USED FOR POST-DILATATION 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 17200638 ↗