NC TREK NEO™ 1400250-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08717648232404), received between Feb 28, 2023 and Sep 30, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (32 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949205 ↗
• MalfunctionSep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949068 ↗
• MalfunctionJun 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5X12 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 12 ATMOSPHERES. ANOTHER 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 25363795 ↗
• MalfunctionMay 21, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 2.50X12MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING THE FIRST INFLATION AT 6 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND A XIENCE SKYPOINT WAS IMPLANTED 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 25240658 ↗
• MalfunctionMay 20, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5 X 12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. 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 25232285 ↗
• MalfunctionMar 23, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.50 X 12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), RESISTANCE WITH THE LESION WAS ENCOUNTERED. DURING INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THE NC TREK NEO BDC WAS REMOVED, AND A NEW 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 24665171 ↗
• MalfunctionMar 16, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND 90% STENOSIS. THE 2.5X12 MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED WITH THE LESION. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED AND 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 24612124 ↗
• MalfunctionMar 3, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 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 24499809 ↗
• MalfunctionJan 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 75% STENOSIS. THE 2.5X12 MM NC TREK NEO BALLOON DILATATION WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND DURING THE SECOND INFLATION TO 10 ATMOSPHERES THE BALLOON RUPTURED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS TO THE PATIENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950431 ↗
• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. USING A 6-FR SYSTEM, ORBITAL ATHERECTOMY (OAS) WAS PERFORMED AND THE LESION WAS DILATED WITH A 2.50X10MM NON-ABBOTT BALLOON. SUBSEQUENTLY, A 2.50X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS INFLATED FOR ADDITIONAL DILATION; HOWEVER, RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. A 2.50X10MM NON-ABBOTT BALLOON WAS SUCCESSFULLY USED FOR ADDITIONAL DILATIONS AND A 2.50X15MM XIENCE SKYPOINT STENT WAS DEPLOYED. THE 2.50X10MM NON-ABBOTT BALLOON WAS USED ONCE AGAIN FOR POST-DILATION WHICH COMPLETED 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 23633667 ↗
• MalfunctionOct 21, 2025Material Rupture; Difficult to Advance; Material 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) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.5X12MM 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 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 23349281 ↗
• MalfunctionOct 15, 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). THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8ATMS. THE BDC WAS REPLACED WITH A NEW NC TREK BDC AND THE PROCEDURE WAS CONTINUED. 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 23296185 ↗
• MalfunctionSep 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) ARTERY. THE 2.5X12MM 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 6 ATMOSPHERES (ATM). THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 23097332 ↗
• MalfunctionJul 28, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS LEFT CIRCUMFLEX THAT IS 90% STENOSED. THE 2.50X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FELT WITH ANATOMY. THE BDC RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. A NEW NC TREK WAS USED TO SUCCESSFULLY 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 22639583 ↗
• MalfunctionJul 25, 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, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5X12 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 AND RUPTURED. THE BALLOON WAS REMOVED AND 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 22613216 ↗
• MalfunctionJul 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED AND RESISTANCE WITH MET WITH ANATOMY. ONCE AT THE LESION, THE BDC WAS INFLATED AND RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. A NEW NC TREK 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 22535692 ↗
• MalfunctionMay 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS OF A 90% STENOSED MID LEFT ANTERIOR DESCENDING (MLAD) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 22029330 ↗
• 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 MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X12MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 13 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 21102395 ↗
• MalfunctionJan 6, 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 MID LEFT ANTERIOR DESCENDING CORONARY THAT IS 90% STENOSED. A 2.50X12MM NC TREK BALLOON DILATATION CATHETER MET RESISTANCE DUE TO ANATOMY DURING ADVANCEMENT, BUT ULTIMATELY CROSSED. THE NC TREK BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE AFTER WHICH A XIENCE DRUG-ELUTING STENT WAS DEPLOYED. 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 21081617 ↗
• MalfunctionSep 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X12 NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE. THE BALLOON WAS ADVANCED FOR PRE-DILATION AND RESISTANCE WAS FELT WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES WHEN A RUPTURE OCCURRED. A NEW TREK 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 20176710 ↗
• MalfunctionAug 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATMS). ANOTHER BALLOON WAS USED TO CONTINUE AND 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 19986394 ↗
• MalfunctionAug 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. PREPARATION WAS PERFORMED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. REPORTEDLY, THE 2.50X12 MM TREK BALLOON WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THERE WAS RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY. 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 19954045 ↗
• MalfunctionMay 20, 2024Material Rupture; Material Rupture

  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 MODERATE TORTUOSITY. THE 2.5X12MM 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 5 SECONDS AT 10 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. ATHERECTOMY WAS PERFORMED FOLLOWED BY BALLOONING WITH ANOTHER NC TREK NEO TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355428 ↗
• MalfunctionMar 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). A CUTTING 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 18848815 ↗
• MalfunctionFeb 27, 2024Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), NEGATIVE WAS PULLED WITH THE INDEFLATOR; HOWEVER, MORE AIR THAN NORMAL WAS NOTED TO BE PULLED BACK. DESPITE THE NOTED ISSUE, THE BDC WAS ADVANCED TO THE TARGET LESION AND ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT 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 18793929 ↗