NC TREK 1012447-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 08717648151750), received between Aug 18, 2016 and Jan 29, 2025 — classified as 5 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (36 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 2.50X12MM RX NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE GUIDING CATHETER. DURING REMOVAL, RESISTANCE WAS AGAIN MET WITH THE GUIDING CATHETER AND THE BDC SHAFT WAS NOTED TO BE SEPARATED. THE SEPARATED PORTION WAS SIMPLY REMOVED WITH THE GUIDING CATHETER. ANOTHER NC TREK 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 21264578 ↗
• MalfunctionFeb 26, 2024Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS IMPLANTED. THE NC TREK RX 2.50 X 12MM BALLOON DILATATION CATHETER (BDC) WAS SELECTED TO BE USED. IT WAS NOTED THAT THE PROTECTIVE SHEATH OF THE BDC WAS DIFFICULT TO REMOVE. THE BDC WAS ADVANCED FOR POST-DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE. SEVERAL ATTEMPTS WERE MADE TO INFLATE THE BALLOON AND THE INFLATION DEVICE WAS REPLACED; HOWEVER, THE BALLOON STILL DID NOT INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANTLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784340 ↗
• InjuryOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BIFURCATION OF A LESION IN THE ANTERIOR INTRAVENTRICULAR ARTERY (IVA) AND DIAGONAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 2.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED SUCCESSFULLY IN THE DIAGONAL ARTERY AND REMOVED WITHOUT RESISTANCE. THE XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE NC TREK BALLOON WAS ADVANCED AGAIN IN THE LAD BUT WITHOUT INFLATION. ANOTHER 2.75X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED BUT HAD RESISTANCE WITH THE GUIDING CATHETER. THE SDS WAS REMOVED, HOWEVER, THE STENT DISLODGED IN THE GUIDING CATHETER. THE STENT WAS REMOVED TOGETHER WITH THE GUIDE CATHETER. THE NC TREK BDC WAS THEN REMOVED WITHOUT RESISTANCE BUT THE DISTAL SHAFT SEPARATED AND A PORTION REMAINED IN THE LAD. SURGERY HAD TO BE PERFORMED TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THERE WAS PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999284 ↗
• MalfunctionOct 23, 2023Break; Inflation Problem; Leak/Splash; Material Separation; Improper or Incorrect Procedure or Method; Break; Inflation Problem; Leak/Splash; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN A VERY TORTUOUS VESSEL AND THIS WAS A MYOCARDIAL INFARCTION CASE. TWO OTHER BALLOONS WERE ATTEMPTED BUT COULD NOT ADVANCE. THE 2.5X12 MM NC TREK BALLOON WAS NOT SOAKED PRIOR TO USE AND WAS NOTED TO HAVE A LOOSE SHAFT AND LEAKING AIR DURING INFLATION AND COULD NOT BE INFLATED DURING THE ONLY ATTEMPT TO INFLATE THE DEVICE. WHEN THE DEVICE WAS BEING PLACED BACK INTO THE DISPENSER HOOP THE SHAFT SEPARATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS 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 17990889 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY LESION. THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER WAS USED FOR POST DILATATION OF A STENT; HOWEVER, THERE WAS A FRACTURE OF THE METALLIC PORTION OF THE BALLOON IN THE GUIDING CATHETER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17922230 ↗
• MalfunctionJul 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE FOR FIVE SECONDS; HOWEVER, RUPTURED AT 10 ATMOSPHERES. THEREFORE, ANOTHER 2.50X12MM NC TREK BDC WAS ATTEMPTED TO BE INFLATED; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. ANOTHER NON-ABBOTT 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 17278804 ↗
• MalfunctionJul 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE FOR FIVE SECONDS; HOWEVER, RUPTURED AT 10 ATMOSPHERES. THEREFORE, ANOTHER 2.50X12MM NC TREK BDC WAS ATTEMPTED TO BE INFLATED; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. ANOTHER NON-ABBOTT 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 17278775 ↗
• MalfunctionMay 11, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED. THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION; HOWEVER, RESISTANCE WAS NOTED WHEN CROSSING THE STENT, DUE TO INTERACTION WITH THE UNSPECIFIED GUIDE CATHETER. WHEN THE DEVICE WAS PULLED BACK OUT OF THE GUIDE CATHETER, IT WAS NOTED THAT THE SHAFT HAD SEPARATED. THE SEPARATED PORTION WAS ABLE TO BE PULLED FROM THE GUIDE CATHETER WITHOUT ANY ADDITIONAL INTERVENTION. A NEW NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912083 ↗
• MalfunctionMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SUBMERGED IN STERILE HEPARINIZED NORMAL SALINE DURING DEVICE PREPARATION. THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LESION IN AN UNKNOWN ARTERY. THE BDC WAS ADVANCED TO THE LESION AND POSITIONED FOR POST-DILATATION. DURING THE FIRST INFLATION TO APPROXIMATELY 16 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE BDC WAS REMOVED, WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. ANOTHER NC TREK OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519133 ↗
• MalfunctionFeb 7, 2023Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (DRCA). THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON AND 2.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION; HOWEVER, RESISTANCE WITH ANATOMY WAS NOTED. THE BDC WAS PREPPED IN THE ANATOMY AND RUPTURED AT 9 ATMOSPHERES CONFIRMED VIA CINE. A NON-ABBOTT BALLOON AND A NON-ABBOTT WERE 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 16314795 ↗
• MalfunctionJan 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MODERATE TORTUOSITY AND 75% STENOSIS. A STENT WAS DEPLOYED AND THEN DURING POST DILATATION, THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE TO 14 ATMOSPHERES AND RUPTURED. 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 16159905 ↗
• MalfunctionDec 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE 2.5X12MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED; HOWEVER, THE PROXIMAL SHAFT SEPARATED. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN AS IT WAS A PROXIMAL SEPARATION. ANOTHER SAME SIZE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970395 ↗
• MalfunctionNov 29, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POSTERIOR DESCENDING CORONARY ARTERY WITH MILD TORTUOSITY, HEAVY CALCIFICATION AND 75% STENOSIS. THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED. THE BDC WAS INFLATED TWICE AND RUPTURED AT 16 ATMOSPHERES. 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 15875494 ↗
• MalfunctionNov 9, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED AND WAS INFLATED ONCE FOR PRE-DILATATION AND RUPTURED AT 12 ATMOSPHERES FOR 10 SECONDS. 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 15763767 ↗
• MalfunctionOct 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). ROTABLATION WAS PERFORMED. THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION DUE TO THE HEAVY CALCIFICATION. 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 15532313 ↗
• MalfunctionAug 31, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT COULD NOT REACH THE LESION, AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES. THE BDC WAS EASILY REMOVED FROM THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NEW BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330514 ↗
• MalfunctionJul 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE, BUT RUPTURED AFTER THE FIRST INFLATION, ATMOSPHERES (ATM) UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE 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 15048317 ↗
• MalfunctionJul 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN, CIRCUMFLEX AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. MANY ABBOTT AND NON-ABBOTT DEVICES WERE USED, INCLUDING STENTS, BALLOONS AND GUIDE WIRES, WITHOUT REPORTED ISSUE. A 2.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) SEPARATED DURING ADVANCEMENT IN THE GUIDING CATHETER; HOWEVER, THERE WAS NO RESISTANCE. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN IN THE GUIDING CATHETER AND NO INTERVENTION WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015344 ↗
• MalfunctionJun 11, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.5X12MM TREK RX BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE PROXIMAL SHAFT SNAPPED IN 2 SEPARATE PIECES. THERE WAS NO RESISTANCE DURING WITHDRAWAL AND THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. ANOTHER NC TREK RX 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 14670891 ↗
• MalfunctionApr 1, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING APPEARED INTACT; HOWEVER, UPON OPENING THE 2.50 X 12MM NC TREK RX BALLOON DILATATION CATHETER (BDC), A 2.5 X 15MM NC TREK BDC WAS IN THE HOOP. THE DEVICE WAS NOT USED, THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973200 ↗
• MalfunctionMar 18, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED RIGHT CORONARY ARTERY (RCA). THE 2.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS UNABLE TO ADVANCE TO THE TARGET LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE NOTED WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13803074 ↗
• MalfunctionMar 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN NC TREK 2.50X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED. HOWEVER, WHILE IN THE PATIENT, IT WAS OBSERVED DYE STARTED TO LEAK FROM THE SHAFT. THEREFORE, THE BDC WAS REMOVED AND REPLACED WITH AN NC TREK 2.50X12MM. HOWEVER, THE SAME ISSUE OCCURRED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZED NC TREK, BUT AGAIN, DYE LEAKED FROM THE SHAFT. THE DEVICE WAS REMOVED AND REPLACED. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. 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 13671630 ↗
• MalfunctionMar 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN NC TREK 2.50X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED. HOWEVER, WHILE IN THE PATIENT, IT WAS OBSERVED DYE STARTED TO LEAK FROM THE SHAFT. THEREFORE, THE BDC WAS REMOVED AND REPLACED WITH AN NC TREK 2.50X12MM. HOWEVER, THE SAME ISSUE OCCURRED. THE DEVICE WAS REMOVED AND REPLACED ANOTHER SAME SIZED NC TREK, BUT AGAIN, DYE LEAKED FROM THE SHAFT. THE DEVICE WAS REMOVED AND REPLACED. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. 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 13671482 ↗
• MalfunctionMar 1, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A PROXIMAL OBTUSE MARGINAL. AN NC TREK 2.5 X 12MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED BUT WAS NOT ABLE TO CROSS THE TARGET LESION DUE TO PATIENT ANATOMY. THEREFORE, THE BDC WAS REMOVED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURNED DEVICE ANALYSIS REPORTED THE HYPOTUBE WAS SEPARATED 55.4CM DISTAL TO THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636785 ↗
• MalfunctionJan 13, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. A 2.50 X 12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUES. HOWEVER, DURING THE THIRD INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN AT THIS TIME HOW THE TARGET LESION WAS TREATED. 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 13252544 ↗