NC TREK 1012449-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 08717648151866), received between Sep 15, 2016 and Feb 11, 2026 — classified as 6 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (52 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE OF THE 3.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC), THERE WAS RESISTANCE DURING ADVANCEMENT AND REMOVAL WITH THE GUIDING CATHETER. THE SHAFT SEPARATED IN TWO PIECES INSIDE THE GUIDING CATHETER SO THE GUIDING CATHETER WAS REMOVED. 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 24318775 ↗
• MalfunctionMay 2, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THERE WAS SEVERE STENOSIS AFTER ANGIOGRAPHY WAS PERFORMED. AN UNSPECIFIED STENT WAS IMPLANTED AND POOR PROXIMAL STENT DILATATION WAS NOTED AND THE 3.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT PREPPED OUTSIDE THE ANATOMY OR SOAKED PRIOR TO USE. THE BDC WAS INFLATED ONCE TO 12 ATMOSPHERES BUT IT DID NOT INFLATE AS INTENDED AND UPON REMOVAL IT WAS FOUND THAT THE BALLOON WAS LEAKING FLUID. ANOTHER SAME SIZE 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 21954402 ↗
• MalfunctionSep 25, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH TORTUOSITY. THE 3X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE SHAFT OF THE BDC SEPARATED OUTSIDE THE ANATOMY. THEREFORE, BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BDC WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304563 ↗
• MalfunctionMar 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC), WHEN SWABBING THE SHAFT OF THE DEVICE WITH SALINE, THE DEVICE SEPARATED INTO 2 PIECES. PREPARATION WAS PERFORMED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 18975252 ↗
• InjuryMar 4, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON WOULD NOT DEFLATE. THEREFORE, THE BALLOON WAS INFLATED AND DEFLATED AGAIN AND THE BALLOON WAS ABLE TO BE DEFLATED. HOWEVER, THE BALLOON DEFLATION WAS NOTED TO BE SLOW. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, FURTHER REVIEW OF THE INFORMATION FOUND THAT WHILE THE BALLOON WAS BEING INFLATED THE PATIENT EXPERIENCED BLOCKED BLOOD FLOW AND CHEST PAIN; HOWEVER, THE BLOOD FLOW WAS RESOLVED UPON DEFLATION AND REMOVAL OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 18833136 ↗
• MalfunctionNov 14, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS. THE 3.0X12MM NC TREK DID NOT CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL. THE PATIENT WAS NOT TREATED WITH ANY OTHER DEVICE. 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 18135607 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 3.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A NEW NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321570 ↗
• MalfunctionJun 30, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN LEFT ANTERIOR DESCENDING ARTERY. THE 3.00X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE AND A LEAK WAS DETECTED AT THE SHAFT ABOUT 10CM NEAR THE 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 17240537 ↗
• MalfunctionMay 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.00X12MM NC TREK BALLOON DILATATION CATHETER BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THEN, THE BDC WAS USED FOR PRE-DILATATION WITHOUT ISSUE; FOLLOWED BY STENT IMPLANTATION. THE BDC WAS ADVANCED AGAIN TO THE TARGET LESION FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 5 ATMOSPHERES (ATM) DURING THE SECOND INFLATION. 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 BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887611 ↗
• MalfunctionMar 3, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS UNSPECIFIED LESION. THE 3.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND MET RESISTANCE WITH ANATOMY. WHEN INFLATING THE BDC DURING THE FIRST INFLATION IT RUPTURED AT 12 ATMOSPHERES. DURING REMOVAL OF THE BDC RESISTANCE WITH ANATOMY WAS NOTED. ANOTHER NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479100 ↗
• MalfunctionFeb 4, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED THROUGH A NON-ABBOTT GUIDE EXTENSION CATHETER FOR PRE-DILATATION WHEN RESISTANCE WAS MET WITH THE DISTAL TIP OF THE CATHETER. THE BDC WAS REMOVED WITH RESISTANCE FROM THE CATHETER AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300820 ↗
• MalfunctionDec 19, 2022Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 90% STENOSIS, HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE BDC HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT BUT CROSSED THE LESION, HOWEVER, IT WAS NOTED TO HAVE A LEAK DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATMS). THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL, HOWEVER, THE DEVICE WAS REMOVED INDEPENDENTLY. ANOTHER NC TREK RX BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE 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 16010391 ↗
• MalfunctionDec 1, 2022Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED WITH STRONG RESISTANCE DUE TO HEAVY CALCIFICATION, WHEN THE PROXIMAL END OF THE BDC SEPARATED IN 2 PIECES OUTSIDE OF THE PATIENT ANATOMY PRIOR TO REACHING THE TARGET LESION. THE BDC WAS REMOVED WITH RESISTANCE FROM THE CALCIFIED ANATOMY, AND A NEW, SAME SIZE NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO SNARE WAS REQUIRED AS THE DEVICE SEPARATED OUTSIDE OF THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15897179 ↗
• MalfunctionOct 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BEFORE USE, IT WAS NOTED THAT THERE WAS LEAKAGE AROUND THE HUB OF THE 3X12MM NC TREK BALLOON DURING PREP FOR USE. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER RX NC TREK BALLOON WAS USED SUCCESSFULLY 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 15661957 ↗
• MalfunctionOct 10, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 3.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY. DURING THE FIRST INFLATION THE BDC RUPTURED AT 12 ATMOSPHERES. 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 15571802 ↗
• MalfunctionOct 4, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 75% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AS THE 3X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING BACKLOADED ONTO THE GUIDE WIRE AND ADVANCED INTO THE GUIDE CATHETER (GC) WITH DIFFICULTY, THE PROXIMAL SHAFT OF THE BDC BECAME SEPARATED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537106 ↗
• MalfunctionSep 24, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FROM THE ANATOMY AND INFLATED ONE TIME TO 12 ATMOSPHERES (ATM) AND HELD FOR 10 SECONDS WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477127 ↗
• MalfunctionSep 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 90% STENOSIS, HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH NO RESISTANCE AND USED FOR POST DILATATION AFTER A STENT WAS IMPLANTED BUT THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE (RBP) OF 12 ATMOSPHERES (ATMS) FOR 10 SECONDS DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE UPON REMOVAL. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS SOAKED IN SALINE AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE UPON REMOVAL OF THE PROTECTIVE SHEATH. 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 15442494 ↗
• MalfunctionSep 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. THE 3.0X12MM NC TREK BALLOON DILATATION CATHETER WAS INFLATED TO 13 ATMOSPHERES FOR 10 SECONDS; HOWEVER, THE BALLOON RUPTURED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348422 ↗
• InjuryAug 18, 2022Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX CORONARY ARTERY. THE 3.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 26 ATMOSPHERES AND THE CONTRAST MIX WAS 50/50. THE BALLOON DID NOT DEFLATE AT ALL AFTER DILATATION. THE DEVICE WAS WITHDRAWN INFLATED AND OCCLUSION OF THE CORONARY ARTERY OCCURRED. THE OCCLUSION WAS TREATED WITH A 3.5X12 MM NC BALLOON AND A STENT. THE WAS PATIENT WAS FINE AND THEY WERE DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15249147 ↗
• MalfunctionJul 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY. A NON-ABBOTT STENT WAS DEPLOYED AND A 3.0X12MM NC BALLOON DILATATION CATHETER WAS ADVANCED FOR POST DILATATION; HOWEVER, RUPTURED AT 12 ATMOSPHERES. ANOTHER 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 15117270 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 90% STENOSIS, MODERATE CALCIFICATION AND WITHOUT TORTUOSITY. THE 3.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) MET NO RESISTANCE DURING ADVANCEMENT AND WAS USED FOR PRE-DILATATION BUT RUPTURED ON THE FIRST INFLATION AT 4 ATMOSPHERES (ATMS) FOR 10 SECONDS. THE BDC WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH AND THERE WAS NO RESISTANCE DURING REMOVAL OF THE BDC FROM THE ANATOMY. ANOTHER SAME SIZED NC TREK BDC 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 15093593 ↗
• MalfunctionJul 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE 3X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS OPENED WHEN IT WAS NOTED THAT THE SHAFT OF THE BDC WAS SEPARATED INTO PIECES. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER 3X12MM NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060555 ↗
• MalfunctionJun 24, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). THE 3.00X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND WAS ATTEMPTED TO BE DILATED; HOWEVER THE BALLOON FAILED TO INFLATE WHICH INDICATED A POSSIBLE LEAK. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE NC TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808888 ↗
• MalfunctionJun 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY CALCIFIED VESSEL WITHOUT TORTUOSITY IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. PRIOR TO USE THE BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. AFTER A STENT WAS DEPLOYED, THE 3.0X12MM NC TREK BDC WAS USED FOR POST DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 15 ATMOSPHERES (ATMS) FOR FIVE SECONDS, THE BALLOON RUPTURED. THERE WAS NO RESISTANCE DURING ADVANCEMENT AND REMOVAL. ANOTHER SAME SIZE NC TREK 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 14601838 ↗