NC TREK 1012448-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08717648151811), received between Nov 16, 2016 and Oct 30, 2025 — classified as 3 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.75X12MM RX NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE GUIDE WIRE INTO THE PATIENT ANATOMY HOWEVER RESISTANCE WAS MET WITH THE GUIDE WIRE THEREFORE THE BDC WAS REMOVED. IT WAS THEN NOTED THE PROXIMAL HYPOTUBE WAS SEPARATED. 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 23425654 ↗
• MalfunctionJun 18, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 80% STENOSED. DURING PREPARATION, THE 2.75X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPPED PRIOR TO REMOVING THE PROTECTIVE SHEATH/STYLET. THE NC TREK BDC TIP COULD NOT ADVANCE OVER A 0.014" UNSPECIFIED GUIDEWIRE. DURING REMOVAL OF THE NC TREK BDC FROM THE GUIDEWIRE, RESISTANCE WAS FELT. AN UNSPECIFIED BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287306 ↗
• MalfunctionOct 6, 2023Failure to Fold; Difficult to Remove; Deformation Due to Compressive Stress; Failure to Fold; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED STENT HAD BEEN IMPLANTED; HOWEVER, DUE TO POOR APPOSITION A 2.75X12MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED AND INFLATED TWICE TO 16 ATMOSPHERES TO FULLY APPOSE THE STENT. THE BDC FULLY DEFLATED; HOWEVER, DID NOT FOLD BACK PROPERLY AND RESISTANCE WAS FELT WITH THE 7F GUIDE CATHETER DURING REMOVAL OF THE BDC. AFTER REMOVING THE BDC THE SHAFT WAS NOTED TO BE BENT. IT WAS ALSO NOTED THAT RESISTANCE WAS FELT WHEN REMOVING THE PROTECTIVE SHEATH. ANOTHER DEVICE 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 17886630 ↗
• MalfunctionFeb 17, 2023Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS NOTHING SPECIAL OR DIFFICULT ABOUT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND 75% STENOSIS. THE LESION WAS STENTED AND THE 2.75 X 12 MM NC TREK BALLOON WAS ADVANCED FOR POST-DILATATION. THE BALLOON DID NOT INFLATE. THE INFLATION DEVICE AND THE 3 WAY STOPCOCK WERE REPLACED AND AGAIN INFLATION WAS ATTEMPTED BUT THE BALLOON DID NOT INFLATE AND THE DEVICE WAS LOSING PRESSURE. WHEN THE DEVICE WAS REMOVED, THE BALLOON WAS NOTED TO HAVE A PORTION HANGING OFF BUT IT WAS NOT COMPLETELY SEPARATED. A NEW UNSPECIFIED 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 16398158 ↗
• MalfunctionOct 12, 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 THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY AND 90% STENOSIS. THE 2.75X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION BEFORE ROTABLATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 8 ATMOSPHERES. THE DEVICE WAS NOT SOAKED IN SALINE PRIOR TO USE. 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 15588483 ↗
• InjuryOct 11, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED PRIOR TO USE. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE AND UNDERWENT A CORONARY INTERVENTION. THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BDC WAS ADVANCED TO POST-DILATE THE VESSEL AND WAS INFLATED ONE TIME TO 16 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED RESULTING IN A CORONARY DISSECTION WHICH CAUSED A DISTAL BLOOD FLOW OBSTRUCTION. AN UNSPECIFIED STENT WAS IMPLANTED TO COVER THE DISSECTION AND RESTORE THE DISTAL BLOOD FLOW, AND ANOTHER 2.75X12MM NC TREK BDC SUCCESSFULLY COMPLETED POST-DILATATION OF THE VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 15577577 ↗
• MalfunctionOct 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, ECCENTRIC LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, MODERATE CALCIFICATION, AND MILD TORTUOSITY. THE 2.75X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND USED FOR PRE-DILATATION, HOWEVER, THE BALLOON WAS INFLATED UP TO 13 ATMOSPHERES (ATMS) FOR 10 SECONDS IN THE FIRST ATTEMPT AND RUPTURED AT 10 ATMS. THE CATHETER WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. A NON-ABBOTT DEVICE 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 15551037 ↗
• MalfunctionAug 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TWICE TO 10 ATMOSPHERES (ATM) WHEN AIR WAS NOTED AS LEAKING, OUTSIDE THE PATIENT, WHILE THE BALLOON WAS PRESSURIZED. THE BDC WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283408 ↗
• MalfunctionJul 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, NO TORTUOSITY, AND 75% STENOSIS. THE 2.75X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BDC WAS INFLATED ONCE AND THEN RUPTURED BELOW THE NOMINAL PRESSURE; HOWEVER, THE EXACT PRESSURE IS NOT KNOWN. 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 15089126 ↗
• MalfunctionMar 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED, DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. PRE-DILATATION WAS PERFORMED, AND A NON-ABBOTT STENT WAS DEPLOYED. POST-DEPLOYMENT, A 2.75X 12MM NC TREK BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO 8 TO 10 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. 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 13677063 ↗
• MalfunctionJan 12, 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 LEFT ANTERIOR DESCENDING ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND HEAVILY TORTUOUS. THE NC TREK BALLOON DILATATION CATHETER WAS ADVANCED BUT FAILED TO REACH THE TARGET LESION. RESISTANCE WAS NOTED DURING REMOVAL. 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 13240063 ↗
• MalfunctionDec 20, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 99% STENOSED, HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.75X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL. A NON-ABBOTT BALLOON WAS USED TO CONTINUE 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 13043115 ↗
• MalfunctionDec 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER REMOVING THE 2.75X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) FROM THE DISPENSER COIL, THE SHAFT WAS SEPARATED ON THE TABLE. THERE WAS NO RESISTANCE REMOVING THE DEVICE FROM THE COIL AND NO DAMAGE WAS NOTED TO THE PACKAGING. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A NEW NC TREK 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 13005581 ↗
• MalfunctionNov 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, 80% STENOSED LESION IN THE MID CIRCUMFLEX (MCX) ARTERY. A 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS POSITIONED AT THE TARGET LESION BUT THE HYPOTUBE AND THE CATHETER HUB SEPARATED, AND THE BALLOON COULD NOT BE INFLATED TO PERFORM DILATATION. THE DEVICE WAS SIMPLY REMOVED FROM THE ANATOMY, NO INTERVENTION WAS REQUIRED. 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 12756044 ↗
• 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 12481852 ↗
• MalfunctionAug 18, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE LEFT CIRCUMFLEX (PROXIMAL TO MIDDLE) THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON DILATATION CATHETER ADVANCED TO THE TARGET LESION WITH RESISTANCE, AND THE PROXIMAL SHAFT WAS BROKEN INTO TWO PIECES BEFORE BALLOON INFLATION. A NON-ABBOTT DILATATION CATHETER WAS USED 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 12339415 ↗
• MalfunctionJun 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 90% STENOSED LESION IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BDC WAS INFLATED 1 TIME TO 14 ATMOSPHERES (ATM) AND HELD PRESSURE FOR 10 SECONDS WITHOUT ISSUE BUT RUPTURED UPON THE 2ND INFLATION AT 14 ATM FOR 15 SECONDS. THE DEVICE WAS SIMPLY REMOVED, AND ANOTHER SAME SIZE 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 11988253 ↗
• MalfunctionMay 3, 2021Difficult to Insert; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Insert; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR ARTERY (LAD). IT WAS NOTED THAT THE 2.75X12MM NC TREK'S SHAFT WAS BENT WHEN REMOVING FROM THE PACKAGING; HOWEVER, PHYSICIAN DECIDED TO PROCEED AND ATTEMPT TO INSERT THE DEVICE INTO A TUOGHY. THE SHAFT BECAME SEPARATED AND NO RETRIEVAL PROCESS WAS NECESSARY AS THE DEVICE HAD NOT ENTERED THE PATIENT'S ANATOMY. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 11764269 ↗
• MalfunctionApr 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY THAT WAS 95% STENOSED. FOR PRE-DILATATION, A 2.75X12MM NC TREK BALLOON WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND INFLATED TWICE AT 12 ATMOSPHERES WHEN IT RUPTURED. THE DEVICE WAS REMOVED AND A SAME SIZE MINI TREK 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 11682104 ↗
• MalfunctionMar 26, 2021Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED:DURING PREP, THE BALLOON WAS SLIGHTLY INFLATED TO CHECK FOR ANY LEAK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575176 ↗
• MalfunctionMar 24, 2021Material Separation; Failure to Advance; Material Separation; Failure to Advance

  SUBSEQUENT TO THE INITIAL FILED REPORT, ADDITIONAL INFORMATION WAS REPORTED. THE SHAFT SEPARATED OUTSIDE THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566322 ↗
• MalfunctionJan 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. AN UNSPECIFIED 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 11174144 ↗
• MalfunctionNov 3, 2020Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM TREK BALLOON AND A 2.5X18MM XIENCE XPEDITION STENT WAS DEPLOYED. DURING POST DILATATION A 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, ADVANCING THROUGH AN UNSPECIFIED GUIDING CATHETER RESISTANCE WAS MET. THE BDC WAS THEN REMOVED AND RE-INSERTED THROUGH THE GUIDING CATHETER. ONCE AGAIN RESISTANCE WAS MET WITH ANATOMY AND THE DEVICE WAS REMOVED. UPON REMOVING IT WAS NOTED THAT THE SHAFT OF THE BDC WAS BROKEN AND KINKED. ANOTHER SAME SIZE NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778856 ↗
• MalfunctionSep 3, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY. A 2.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION, BUT THE BALLOON FAILED TO INFLATE AND WAS LOSING PRESSURE. A SAME SIZED NC TREK BDC 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 10487960 ↗
• MalfunctionAug 14, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED AN UNSPECIFIED CORONARY ARTERY. THERE WAS RESISTANCE NOTED DURING ADVANCEMENT WITH THE ANATOMY AND THE NC TREK RX PROXIMAL SHAFT SEPARATED IN TWO PIECES WELL OUTSIDE THE PATIENT. ANOTHER NC TREK WAS USED TO 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 Consequences Or Impact To Patient

  MAUDE report 10408859 ↗