NC TREK 1012449-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 08717648151873), received between Aug 19, 2016 and Nov 13, 2025 — classified as 3 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (38 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE HT BMW UNIVERSAL II 190CM J GUIDE WIRE (GW) WAS BEING USED IN THE PROCEDURE; HOWEVER, WHEN ATTEMPTING TO LOAD AN A 3X15MM NC TREK BALLOON DILATATION CATHETER (BDC), FRICTION WAS NOTED AND THE BDC BECAME STUCK WITH GW. THEREFORE, THE GW AND BDC HAD TO BE REMOVED AS A SINGLE UNIT. ANOTHER BMW GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544723 ↗
• MalfunctionJan 16, 2025Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. AN UNSPECIFIED STENT WAS IMPLANTED AND THE 3.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. THE BALLOON WAS USED FOR POST-DILATATION. DURING USE OF THE BALLOON, THE STENT EXPANDED AND CAUSED LONGITUDINAL COMPRESSION OF THE BALLOON AND THE DEVICE HELD PRESSURE BUT THE BALLOON FAILED TO INFLATE. ANOTHER 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 21171866 ↗
• MalfunctionNov 8, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER BECAME STUCK WITH THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WHEN ATTEMPTING TO ADVANCE OVER THE WIRE. WITH A LITTLE FORCE THE SHAFT OF THE GUIDE WIRE SEPARATED WHEN ATTEMPTING TO REMOVE. THE BALLOON AND GUIDE WIRE WERE REMOVED AS A UNIT; THE SEPARATED PORTION WAS REMOVED VIA SNARE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY 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 20641183 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIALLY PRESENTED WITH INFEROPOSTERIOR MYOCARDIAL INFARCTION (MI) DUE TO OCCLUDED THROMBOTIC LESION AT THE CIRCUMFLEX (CX) ARTERY. TREATMENT WAS NOT REPORTED; HOWEVER, ONE DAY LATER, THE PATIENT HAD COMPLAINTS OF CHEST PAIN AND VENTRICULAR TACHYCARDIA AND WAS TAKEN BACK TO THE CATH LAB FOR A SECOND PROCEDURE. THIS SECOND PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM (OAS) THERAPY WAS USED, FOLLOWED BY THE IMPLANTATION OF AN UNSPECIFIED STENT. CONTINUING TO TREAT THE PREDOMINATELY FIBRO-LIPIDIC PROXIMAL LESION, A 3.0X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED. THE BALLOON WAS INFLATED TO 16 ATMOSPHERES WHEN A VESSEL PERFORATION OCCURRED. BALLOON INFLATION WAS USED TO TREAT THE DISSECTION. HOWEVER, IN-STENT THROMBOSIS OCCURRED WITH THE IMPLANTED UNSPECIFIED STENT. THE NC TREK BDC DID NOT CAUSE OR CONTRIBUTE TO THE MICRO THROMBUS. THE PATIENT WAS STABLE POST PROCEDURE AND COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY. THE PATIENT EXPERIENCED TWO EPISODES OF CARDIAC ARREST RELATED TO

  Patient problems: Perforation of Vessels

  MAUDE report 20318882 ↗
• MalfunctionSep 19, 2024Failure to Advance; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Failure to Advance; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER FAILED TO CROSS DUE TO ANATOMY. THE DEVICE WAS NOTED TO BE KINKED AT THE SHAFT AND THE DEVICE TORN. A NEW NC TREK 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 20258274 ↗
• MalfunctionMar 13, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CORONARY ARTERY THAT IS 30% STENOSED. AFTER USE WITH THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER, THE DEVICE MET STRONG RESISTANCE DURING REMOVAL. ANOTHER UNSPECIFIED DEVICE 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 18899023 ↗
• MalfunctionNov 8, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ADVANCED AND USED AS A TRACK. A STENT WAS IMPLANTED AND A NON-COMPLIANT BALLOON WAS USED FOR POST DILATATION. THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE STENT BUT WITH SIGNIFICANT RESISTANCE WITH THE GUIDE WIRE, COULD NOT REACH THE SITE WHERE IT NEEDED TO BE DILATED. A 6FRENCH (FR) GUIDING CATHETER ALSO FAILED TO PASS INTO THE ARTERY. THE HT BMW UNIVERSAL II GUIDE WIRE AND THE NC TREK BDC WERE REMOVED TOGETHER AS A UNIT. ANOTHER NON-ABBOTT GUIDE WIRE AND A SMALLER SIZE NON-ABBOTT BALLOON WERE USED TO COMPLETE THE PROCEDURE. HOWEVER, DILATATION OF THE STENT MAY NOT BE COMPLETE WHICH MAY LEAD TO IN-STENT RESTENOSIS. 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 18096632 ↗
• MalfunctionSep 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE 3.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED FROM THE COIL, THE HUB/PROXIMAL SHAFT OF THE DEVICE WAS NOTED TO BE SEPARATED IN TWO PIECES. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781423 ↗
• MalfunctionJun 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A UNSPECIFIED ARTERY. THE 3.00X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE; HOWEVER, THE BDC SNAPPED DURING USE. 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 17226267 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL ARTERY. THERE WERE 16 BALLOONS USED IN THE PROCEDURE FOR DILATATION. HOWEVER, 8 OUT OF THE 16 BALLOONS USED HAD ISSUES. TWO NC TREK BALLOONS, 3.0X8MM AND 4.0X8MM, LOST PROFILE. FOUR NC TREK BALLOONS, 2.0X20MM, 2.5X15MM, 3.0X15MM AND 3.0X20MM, HAD BALLOON RUPTURES. ANOTHER 2 TREK BALLOONS, 2.25X12MM AND 2.5X15MM, ALSO HAD BALLOON RUPTURES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 17127817 ↗
• MalfunctionMay 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE LEFT CIRCUMFLEX(LCX) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.00X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TWICE; HOWEVER, A RUPTURE OCCURRED BEFORE THE BALLOON REACHED RATED BURST PRESSURE (RBP). THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER NC TREK WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869619 ↗
• MalfunctionFeb 24, 2023Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS UNSPECIFIED LESION. A 3.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO CROSS THE LESION; HOWEVER, BLOOD WAS NOTED IN THE INFLATION DEVICE AND THE BDC WAS REMOVED. IT WAS NOTED THE BDC WAS NOT AIR ASPIRATED PRIOR TO USE. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16437769 ↗
• MalfunctionFeb 15, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT ISSUE. THE DEVICE WAS SOAKED IN NORMAL SALINE (NS). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379874 ↗
• MalfunctionJan 10, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 3.00X15MM NC TREK BALLOON DILATATION CATHETER (BDC) THROUGH THE GUIDING CATHETER, RESISTANCE WAS NOTED AND THE SHAFT SEPARATED INTO TWO OR MORE PIECES. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS CONTINUED USING ANOTHER BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134719 ↗
• MalfunctionDec 27, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID AND DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 100% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.0X15MM NC TREK 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. THERE WAS RESISTANCE WITH THE LESION DURING ADVANCEMENT AND WAS ATTEMPTED TO BE INFLATED BUT THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 18 ATMOSPHERES (ATMS) FOR 5 SECONDS. THERE WAS NO RESISTANCE DURING REMOVAL. A NON-ABBOTT 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 16056879 ↗
• MalfunctionNov 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WHEN ADVANCING OVER AN UNSPECIFIED GUIDE WIRE AND SEPARATED IN TWO SEPARATE PIECES. THE BDC SEPARATED OUTSIDE OF THE ANATOMY. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790195 ↗
• MalfunctionOct 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS A KISSING BALLOON TECHNIQUE TO TREAT THE LEFT ANTERIOR DESCENDING AND CIRCUMFLEX CORONARY ARTERIES. THE 3.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED SUCCESSFULLY IN PART OF THE PROCEDURE AND WAS REMOVED FROM THE PATIENT. DURING RE-HOOPING [RE-PACKAGING] OF THE BALLOON TO KEEP IT FOR A LATER POINT IN THE PROCEDURE, THE BALLOON SEPARATED FROM THE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AS THIS OCCURRED OUTSIDE THE PATIENT. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597927 ↗
• MalfunctionOct 1, 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 MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. A 3X15MM 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) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NEW BDC 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 15522623 ↗
• MalfunctionSep 30, 2022Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE 3.0X15 MM NC TREK WAS ADVANCED TO THE LESION AND INFLATED TWICE; HOWEVER, THE PROXIMAL SHAFT MAY HAVE FIRST KINKED, THEN SEPARATED OUTSIDE THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521435 ↗
• InjurySep 24, 2022Entrapment of Device; Inflation Problem; Improper or Incorrect Procedure or Method; Entrapment of Device; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% STENOSIS AND NO CALCIFICATION. THE 3.0X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS SUCCESSFULLY INFLATED, HOWEVER, THE PROXIMAL SEGMENT DID NOT YIELD DESPITE BALLOON DILATATION. THE BALLOON HAD RESISTANCE DURING REMOVAL WITH THE IN-STENT RESTENOTIC LESION AND COULD NOT BE REMOVED WITH MODERATE FORCE FOLLOWING DEFLATION. THE PATIENT REQUIRED CORONARY ARTERY BYPASS GRAFTING (CABG) OF THE OBTUSE MARGINAL (OM) BRANCH THEN WITHDREW THE GUIDE CATHETER, BALLOON, AND GUIDE WIRE ALL TOGETHER IN ONE BLOCK USING A LOT OF FORCE. NOTHING WAS LEFT INSIDE THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT HAD PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15477355 ↗
• MalfunctionSep 14, 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 TO A MILDLY TORTUOUS MID RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE NC TREK BALLOON DILATATION RUPTURED AT 20 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER SAME SIZE NC TREK WAS USED TO SUCCESSFULLY POST DILATE 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 15419200 ↗
• MalfunctionSep 1, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR DESCENDING ARTERY. THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) AND THE HT BALANCE MIDDLEWEIGHT UNIVERSAL II (BMW) GUIDE WIRE WERE POSITIONED TOGETHER. IT WAS NOTED THE BDC MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT. DURING REMOVAL THE BALLOON WAS OBSERVED TO BE STUCK IN THE DISTAL PART OF THE BMW UNIVERSAL II GUIDE WIRE. BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. AFTER THE PROCEDURE THE BALLOON WAS REMOVED FROM THE GUIDE WIRE AND IT WAS NOTED THAT THE DISTAL HYDROPHILIC LAYER OF THE GUIDE WIRE WAS LOST. IT WAS PERCEPTIBLE TO THE TOUCH. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336660 ↗
• MalfunctionAug 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER REMOVAL FROM THE PACKAGE, DURING DEVICE PREPARATION AND BEFORE USE OF THE 3.0X15MM NC TREK, THE DISTAL PART OF THE DEVICE INCLUDING THE BALLOON SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325146 ↗
• MalfunctionJul 8, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS VESSEL IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). ATHERECTOMY WAS USED. THE 3.0X15MM NC TREK RX BALLOON DILATATION CATHETER WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE BUT HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON RUPTURED DURING THE FIRST ATTEMPT OF INFLATION AT 18 ATMOSPHERES (ATMS) FOR 2 SECONDS. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING REMOVAL. A NON-ABBOTT 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 14958458 ↗
• MalfunctionJun 13, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. THE 3.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING SECOND INFLATION AT 18 ATMOSPHERES. ANOTHER UNSPECIFIED 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 14676701 ↗