NC TREK 1012452-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08717648152023), received between Sep 13, 2016 and Jan 13, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Leak/Splash; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Leak/Splash; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THE 3.75X12 MM NC TREK HAD RESISTANCE DURING REMOVAL WITH THE [GUIDING] CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21142552 ↗
• MalfunctionDec 27, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT UPON REMOVING THE 3.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) FROM THE PACKAGING, THE END OF THE STYLET WAS BENT OUTSIDE THE GUIDE WIRE EXIT NOTCH; THEREFORE, THE STYLET COULD NOT BE REMOVED FROM THE DEVICE AND THE BDC WAS NO ABLE TO BE USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028770 ↗
• InjuryJul 23, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING ADVANCEMENT AND REMOVAL OF THE 3.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS NOTED WITH THE GUIDE CATHETER. DURING REMOVAL THE BALLOON SEPARATED FROM THE DELIVERY SYSTEM DISTALLY. THEREFORE, A PROBE WAS USED TO ATTEMPTED TO REMOVE THE SEPARATED BALLOON; HOWEVER, THE BALLOON REMAINED IN THE PATIENT AND WAS EMBEDDED IN THE VESSEL. THERE WAS AN INCREASE OF PROCEDURE TIME AND THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19811913 ↗
• MalfunctionJan 10, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROTECTIVE SHEATH OF THE 3.75X12MM NC TREK BALLOON DILATING CATHETER (BDC) WAS DIFFICULT TO REMOVE. THE DEVICE WAS NOT USED. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483505 ↗
• MalfunctionNov 9, 2023Inflation Problem; Stretched; Improper or Incorrect Procedure or Method; Inflation Problem; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 3.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO INFLATE AFTER REPEATED ATTEMPTS FOR POST DILATATION AT 14 ATMOSPHERES. IT WAS NOTED THE BDC WOULD HOLD PRESSURE; HOWEVER, WOULD NOT INFLATE. THE DEVICE WAS NOT SOAKED PRIOR TO USE. ANOTHER 3.75X12MM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. DEVICE ANALYSIS NOTED THAT THE SHAFT OF THE BDC WAS STRETCHED DISTAL TO THE MID LAP SEAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107852 ↗
• MalfunctionDec 7, 2022Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5X18MM XIENCE SKYPOINT WAS IMPLANTED WITHOUT ISSUE AND STANDARD POST DILATATION WAS PERFORMED WITH THE 3.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC). HOWEVER, THE BALLOON DID NOT FOLD PROPERLY IT WAS NOTED TO BE WINGED ONCE FULLY DEFLATED. DURING REMOVAL RESISTANCE WAS NOTED WITH THE GUIDE CATHETER AND EVERYTHING WAS REMOVED AS A SINGLE UNIT. THE DEVICE WAS COMPLETELY DEFLATED BEFORE ATTEMPTING TO REMOVE. NO OTHER DEVICE WAS NEEDED TO 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 15934338 ↗
• MalfunctionApr 25, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. A 3.75 X 12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER THE BDC MET WITH RESISTANCE DUE TO ANATOMICAL CHALLENGES. THE BDC WAS REMOVED FROM THE PATIENT AND ALSO MET WITH RESISTANCE DUE TO ANATOMICAL CHALLENGES DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS REPORTED. 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 14197691 ↗
• MalfunctionFeb 21, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE RIGHT CIRCUMFLEX. A 3.75X12 MM NC TREK BALLOON DILATATION CATHETER WAS USED BUT DID NOT DEFLATE PROPERLY. THEY WERE ABLE TO EVENTUALLY GET IT DEFLATED BUT IT TOOK AWHILE AND DIDN'T BEHAVE APPROPRIATELY. 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 13569653 ↗
• MalfunctionDec 23, 2021Difficult 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, 99% STENOSED, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT FAILED TO REACH THE TARGET LESION DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS MET WITH THE ANATOMY, 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 13081948 ↗
• MalfunctionDec 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. WHILE ADVANCING THE 3.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) THROUGH THE GUIDING CATHETER, THE PROXIMAL SHAFT OF THE BDC SEPARATED INTO TWO PIECES. THE SEPARATION OCCURRED OUTSIDE OF THE PATIENT'S ANATOMY; THEREFORE, THE SEPARATED PIECES WERE SIMPLY REMOVED. THE GUIDING CATHETER REMAINED IN THE PATIENT AND A NEW UNSPECIFIED 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 12964903 ↗
• MalfunctionSep 28, 2021Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.75X12MM NC TREK BALLOON DILATATION CATHETER (BDC) EXPERIENCED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES, AND THE BDC EXPERIENCED RESISTANCE WITH THE ANATOMY DURING REMOVAL. A 3.5X12MM NC 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 12543848 ↗
• MalfunctionJan 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREP, THE 3.75X12 MM TREK BALLOON DILATATION CATHETER BUBBLES WERE NOTED WHEN NEGATIVE PRESSURE WAS APPLIED. DUE TO THE BUBBLES PRESENT IT WAS DECIDED TO INFLATE THE DEVICE TO SEE IF THERE WAS A LEAK. A PIN SIZED HOLE WAS NOTED AS THE SOURCE OF THE LEAK. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW 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 Patient Involvement

  MAUDE report 11143610 ↗
• MalfunctionNov 2, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH 90% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY. REPORTEDLY, A 3.75 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED (AIR ASPIRATION) INSIDE THE ANATOMY. THE BDC WAS ADVANCED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES. THE BDC WAS SIMPLY REMOVED AND A SAME SIZE NON-ABBOTT BALLOON 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 Consequences Or Impact To Patient

  MAUDE report 10771542 ↗
• MalfunctionSep 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN NC TREK BOX WITH THE OUTER LABELING OF 3.75X12MM CONTAINED AN NC TREK BALLOON WITH THE INNER LABELING OF A 3X15MM NC TREK. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10548933 ↗
• MalfunctionJan 16, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A 3.75X12MM NC TREK BALLOON DILATATION CATHETER WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS AFTER SEVERAL ATTEMPTS DUE TO UNKNOWN REASONS, WHEN THE PROXIMAL SHAFT BECAME SEPARATED. THE DEVICE WAS SIMPLY WITHDRAWN AND NO FURTHER INTERVENTION WAS PERFORMED. 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 9598302 ↗
• MalfunctionAug 28, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT CORONARY ARTERY STENT IMPLANTATION AT A RIGHT CORONARY ARTERY. DURING THE PROCEDURE, A 3.75 X 12 MM NC TREK BALLOON DILATATION CATHETER WAS INFLATED ONCE AT 16 ATMOSPHERES. IT WAS ATTEMPTED TO BE DEFLATED AND HELD NEGATIVE FOR 5 SECONDS, BUT COMPLETELY FAILED TO DEFLATE. THE DEVICE WAS SIMPLY REMOVED AND REPLACED WITH A NON-ABBOTT BALLOON AND THE PROCEDURE CONTINUED SMOOTHLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940708 ↗
• MalfunctionJul 9, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-TORTUOUS, NON-CALCIFIED, 90% STENOSED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. BEFORE USE, A 3.75 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT SIX ATMOSPHERES. NEGATIVE WAS HELD FOR 60 SECONDS TO DEFLATE THE BALLOON, BUT THE BDC COMPLETELY FAILED TO DEFLATE EVEN AFTER SEVERAL ATTEMPTS. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SAME SIZED UNSPECIFIED BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S FINAL OUTCOME IS SATISFACTORY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8771913 ↗
• MalfunctionJan 15, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN CORONARY LESION. DURING THE SECOND INFLATION, THE NC TREK RX 3.75 X 12 MM BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE AND LOT NC TREK BALLOON BUT THIS BALLOON RUPTURED ALSO. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7192260 ↗
• MalfunctionJan 15, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN CORONARY LESION. DURING THE SECOND INFLATION, THE NC TREK RX 3.75 X 12 MM BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE AND LOT NC TREK BALLOON BUT THIS BALLOON RUPTURED ALSO. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7192246 ↗
• MalfunctionJun 20, 2017Insufficient Device Problem Information

  REPORTEDLY, THERE WAS AN ISSUE WITH THREE NC TREK BALLOON DILATATION CATHETERS; HOWEVER, THERE WAS NO INFORMATION AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS OF THE THREE NC TREK CATHETERS FOUND THE FOLLOWING: THE 3.5X8MM NC TREK: THE OUTER MEMBER WAS STRETCHED AND TORN AT THE PROXIMAL SEAL. THE 3.75X12MM NC TREK: THE OUTER MEMBER WAS STRETCHED AT THE PROXIMAL SEAL. THE 2.75X20MM NC TREK: THE HYPOTUBE WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6654839 ↗
• MalfunctionJun 14, 2017Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE NON-TORTUOUS, NON-CALCIFIED, PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.75 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR THE PROCEDURE. THE BDC WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND WOULD NOT INFLATE. A NEW UNSPECIFIED BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641291 ↗
• MalfunctionApr 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. A 3.75X12MM NC TREK BALLOON RUPTURED AT 12 ATMOSPHERES DURING POST DILATATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. 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 6465608 ↗
• MalfunctionMar 30, 2017Inflation Problem; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS NON-TORTUOUS AND NON-CALCIFIED. RESISTANCE WAS FELT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE NC TREK RX 3.75 X 12 THAT WAS BEING USED FOR PRE-DILATATION AND THE BALLOON COMPLETELY FAILED TO INFLATE. THE DEVICE WAS REMOVED FROM THE ANATOMY AND WOULD NOT INFLATE OUTSIDE THE ANATOMY EITHER. IT WAS STATED THAT THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE FROM THE DEVICE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT BALLOON DILATATION CATHETER. ALTHOUGH THERE WAS A DELAY REPORTED, IT WAS NOT CLINICALLY SIGNIFICANT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6446538 ↗
• MalfunctionMar 17, 2017Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE YELLOW PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. THE DEVICE CONTINUED TO BE USED AND AFTER ADVANCING THROUGH THE NON-TORTUOUS VESSEL TO THE NON-CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY, THE NC TREK BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE ANATOMY AND REPLACED WITH ANOTHER SAME SIZE NC TREK 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 Consequences Or Impact To Patient

  MAUDE report 6413874 ↗
• MalfunctionMar 9, 2017Inflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE OF THE HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY, THE NC TREK WAS ADVANCED, BUT WOULD NOT INFLATE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER NC TREK TO SUCCESSFULLY COMPLETE THE PROCEDURE. AFTER THE CASE, INFLATION WAS TESTED OUTSIDE THE ANATOMY, BUT IT STILL WOULD NOT INFLATE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6393338 ↗