NC TREK™ 1012446-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648151699), received between Oct 7, 2016 and Jan 15, 2024 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE MID LEFT CIRCUMFLEX (MLCX) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 2.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURED OCCURRED DURING THE FIRST INFLATION AT 11 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. A CUTTING BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515037 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. PRIOR TO USE THE NC TREK BALLOON DILATION CATHETER (BDC) WAS WAS SOAKED IN SALINE AND WAS PREPPED (AIR ASPIRATION) OUTSIDE THE PATIENT ANATOMY. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON, THE 2.25X12MM NC TREK BDC WAS USED FOR FURTHER PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES (ATM) AFTER 10 MINUTES. THE NC TREK BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED FOR FURTHER PRE-DILATION. 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 16583974 ↗
• MalfunctionApr 28, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS 90% STENOSED. THE 2.25 X 12MM NC TREK FAILED TO CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY 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 14246262 ↗
• MalfunctionApr 13, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE FIRST DIAGONAL ARTERY. A 2.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE ANATOMY TO REACH THE TARGET LESION. UPON REMOVAL, THE DEVICE MET RESISTANCE WITH THE ANATOMY. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY 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 14107940 ↗
• MalfunctionMar 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE RIGHT POSTERIOR LATERAL BRANCH OF THE RIGHT CORONARY ARTERY (RCA). THE 2.25 X 12 MM NC TREK WAS ADVANCED WITHOUT ISSUE, BUT THE PROXIMAL SHAFT SEPARATED BY THE HUB IN TWO PIECES AND WAS REMOVED. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS AND CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892292 ↗
• MalfunctionJan 18, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 100% STENOSIS, DE NOVO LESION IN THE MID LEFT ANTERIOR CORONARY ARTERY. A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION. THEN A 2.25 X 12MM NC TREK RX (BDC) WAS USED FOR ADDITIONAL DILATATION. DURING ADVANCEMENT RESISTANCE WAS FELT DUE TO THE HEAVY CALCIFICATION IN THE LESION; HOWEVER, THE BALLOON REACHED THE TARGET LESION. THE BDC WAS INFLATED FOUR TIMES TO 18 ATMOSPHERE WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT DEVICE 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 13285704 ↗
• MalfunctionSep 16, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THAT THE PROCEDURE WAS TO TREAT A LEFT MAIN (LM) BIFURCATION LESION / LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE LEFT CIRCUMFLEX (LCX) ARTERY. TWO NC TREKS WERE ADVANCED IN THE GUIDING CATHETER WITH RESISTANCE, WHEN THE DEVICES BECAME ENTANGLED WITH EACH OTHER AND COULD NOT BE ADVANCED FURTHER. DURING REMOVAL THERE WAS RESISTANCE BUT THE DEVICES WERE ABLE TO BE REMOVED WITHOUT ISSUE. GUIDE WIRE ACCESS WAS MAINTAINED AND TWO NEW NC TREK DEVICES WERE USED TO SUCCESSFULLY 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 12481844 ↗
• MalfunctionJul 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED VESSEL. WHEN INSERTING THE NC TREK BALLOON INTO THE GUIDE, OUTSIDE THE ANATOMY, THE PROXIMAL SHAFT SEPARATED IN TWO PIECES. THE BALLOON DILATATION CATHETER WAS RETRACTED AND REPLACED WITH A NON-ABBOTT BALLOON 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 12125399 ↗
• MalfunctionJun 25, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED OSTIAL FIRST DIAGONAL ARTERY THAT WAS 90% STENOSED. A 2.25X12MM NC TREK BALLOON FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS ALSO NOTED DURING REMOVAL WITH ANATOMY. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY 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 12068251 ↗
• MalfunctionJul 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED, HEAVILY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. REPORTEDLY, WHEN THE 2.25X12MM NC TREK BALLOON DILATATION CATHETER WAS FIRST INFLATED, THE BALLOON BURST OPEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302027 ↗
• MalfunctionJun 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 2.25X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO NOMINAL PRESSURE AND RUPTURED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187077 ↗
• MalfunctionJan 2, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. WHILE ADVANCING A 2.25X12MM NC TREK BALLOON THRU THE GUIDE CATHETER, RESISTANCE WAS MET AND THE [HUB WITH 3 INCHES OF HYPOTUBE] BROKE OFF. THE DEVICE WAS SIMPLY REMOVED. A NEW BALLOON WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 9540966 ↗
• InjurySep 9, 2019Leak/Splash; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Leak/Splash; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. A 2.25X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED, DILATED THE LESION ONCE, AND WAS REMOVED. UPON REMOVAL THE SHAFT WAS NOTED TO BE KINKED AT 10 CM FROM THE PROXIMAL EDGE. INTRAVASCULAR ULTRASOUND SHOWED INSUFFICIENT INFLATION AND ADDITIONAL DILATATION WAS NEEDED. THE BDC WAS ADVANCED AGAIN; HOWEVER, RESISTANCE WAS FELT AND IT IS UNKNOWN IF IT WAS WITH THE ANATOMY OR ANOTHER DEVICE. THE BDC WAS BEING INFLATED AND BLOOD WAS NOTED IN THE INDEFLATOR. AN ATTEMPT TO REMOVE THE BDC WAS MADE, BUT THE PROXIMAL SHAFT SEPARATED AT 10CM FROM THE PROXIMAL EDGE. THE PROXIMAL PORTION OF THE BDC WAS WITHDRAWN AND THE DISTAL SEPARATED PORTION WAS REMOVED WITH A DOUBLE LUMEN CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.25X8MM NC TREK RX BDC AND DEPLOYMENT OF AN UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976539 ↗
• MalfunctionMar 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MILD TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. A 2.25 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 5 ATMOSPHERES. THE BDC WAS SIMPLY REMOVED WITH NO REPORTED RESISTANCE AND A NON-ABBOTT BDC WAS USED SUCCESSFULLY TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426595 ↗
• MalfunctionJan 30, 2019Difficult to Insert; Material Separation; Deformation Due to Compressive Stress; Difficult to Insert; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT RESISTANCE WAS MET INSERTING A 2.25 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) THROUGH A COPILOT BLEED BACK CONTROL VALVE. THE SHAFT OF THE BDC KINKED AND SEPARATED. AS THE SEPARATION OCCURRED AT A POINT OUTSIDE OF THE ANATOMY, THE DISTAL PART OF THE BDC WAS SIMPLY MANUALLY REMOVED. A NEW 2.25 X 12 MM NC TREK RX BDC WAS ADVANCED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BDC AND THE SAME COPILOT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289863 ↗
• MalfunctionJan 30, 2019Difficult to Insert; Material Separation; Deformation Due to Compressive Stress; Difficult to Insert; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT RESISTANCE WAS MET INSERTING A 2.25 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) THROUGH A COPILOT BLEED BACK CONTROL VALVE. THE SHAFT OF THE BDC KINKED AND SEPARATED. AS THE SEPARATION OCCURRED AT A POINT OUTSIDE OF THE ANATOMY, THE DISTAL PART OF THE BDC WAS SIMPLY MANUALLY REMOVED. A NEW 2.25 X 12 MM NC TREK RX BDC WAS ADVANCED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BDC AND THE SAME COPILOT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289820 ↗
• MalfunctionOct 16, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING USE, THE SHAFT OF THE 2.25X12 NC TREK RX SEPARATED IN TWO PIECES. ANOTHER BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6953243 ↗
• MalfunctionSep 7, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, MID TO PROXIMAL RIGHT CORONARY ARTERY. IT WAS REPORTED THAT THE 2.50 X 12 MM NC TREK WAS ADVANCED FOR PRE-DILATATION OF THE LESION; HOWEVER, RESISTANCE WAS FELT DURING ADVANCEMENT TO THE LESION. THE BALLOON RUPTURED ON THE FIRST INFLATION AT AN UNSPECIFIED PRESSURE, DUE TO THE CALCIFICATION, AND WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE 2.25 X 12 MM NC TREK WAS ADVANCED FOR PRE-DILATATION OF THE LESION; HOWEVER, AGAIN RESISTANCE WAS FELT DURING ADVANCEMENT TO THE LESION. THE BALLOON RUPTURED ON THE FIRST INFLATION AT AN UNSPECIFIED PRESSURE, DUE TO THE CALCIFICATION AND WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. A SMALLER NC TREK BALLOON CATHETER WAS USED SUCCESSFULLY FOR PRE-DILATATION AND A 2.5 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6850454 ↗
• MalfunctionMay 10, 2017Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 2.25X12 MM NC TREK DILATATION CATHETER WAS NOT FLUSHED PRIOR TO USE AND THE PROTECTIVE SHEATH WAS UNABLE TO BE REMOVED. THE DEVICE WAS NOT USED. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6558511 ↗
• MalfunctionMar 13, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED DE NOVO CONCENTRIC LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION BEFORE REACHING 10 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN BDC. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6400676 ↗
• MalfunctionDec 8, 2016Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PREPARATION FOR TREATMENT OF A HEAVILY CALCIFIED, 90% STENOSED, 15MM-LONG LESION IN THE MODERATELY TORTUOUS 2.3MM-DIAMETER RIGHT POSTERIOR DESCENDING CORONARY ARTERY, A 2.25X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS UNPACKAGED WITHOUT DIFFICULTY AND THE DEVICE SOAKED IN SALINE. AIR ASPIRATION OF THE DEVICE WAS PERFORMED WHILE INSIDE OF PATIENT ANATOMY. THE NC TREK RX BDC WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. DURING THE 1ST INFLATION THE BALLOON RUPTURED AT 15 ATMOSPHERES. THE NC TREK RX BDC WAS WITHDRAWN WITHOUT DIFFICULTY. DILATATION WAS COMPLETED USING A 2.5X15 NON-ABBOTT BDC, FOLLOWED BY DEPLOYMENT OF A NON-ABBOT STENT, RESULTING POST-PROCEDURE STENOSIS OF 15%. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156532 ↗
• MalfunctionOct 7, 2016Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSIS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 2.0 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) THROUGH THE LESION; HOWEVER, IT WAS ABLE TO CROSS SUCCESSFULLY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES HELD FOR 5 SECONDS. A 2.25 X 12 MM NC TREK BDC WAS USED AND MET WITH RESISTANCE AS IT WAS ADVANCED TO THE LESION. THIS NC TREK BALLOON ALSO RUPTURED DURING THE FIRST INFLATION AT 13 ATMOSPHERES HELD FOR 5 SECONDS. THE STENOSIS AT THE LESION WAS DECREASED TO 50% AFTER THE USE OF THE REPLACEMENT BDC AND NO ADDITIONAL TREATMENT WAS PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6012349 ↗