NC TREK 1012449-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648151859), received between Nov 9, 2016 and Dec 3, 2025 — classified as 1 injury, 35 malfunctions.

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

• MalfunctionDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY STENOSED LESION IN LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATATION IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES (ATM). ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 23706586 ↗
• MalfunctionDec 11, 2023Material 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 WAS TO TREAT AN UNSPECIFIED VESSEL FOR PERCUTANEOUS CORONARY INTERVENTION. WHEN ADVANCING THROUGH THE SHEATH, THERE WAS RESISTANCE AND THE 3.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) KINKED AND SEPARATED INTO TWO PIECES AT THE SHAFT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304125 ↗
• InjuryOct 26, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OSTIAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THE 3.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED TWICE FOR PRE-DILATATION AND A 3.0X23 MM NON-ABBOTT STENT WAS IMPLANTED. DURING POST-DILATATION WITH THE SAME NC TREK BALLOON, THE BALLOON WAS INFLATED 4 TIMES TO 16 ATMOSPHERES AND NEGATIVE PRESSURE WAS HELD FOR 10 SECONDS FOR DEFLATION. THE BALLOON WAS FULLY DEFLATED UPON REMOVAL; HOWEVER, IT WAS CAUGHT ON THE EDGE OF THE STENT. THERE WAS RESISTANCE AS THE BALLOON WAS PUSHED AND PULLED SEVERAL TIMES WITH FORCE IN AN ATTEMPT TO REMOVE THE BALLOON. THE BALLOON WAS THEN INFLATED AND DEFLATED NUMEROUS TIMES AND IT WAS ULTIMATELY REMOVED; HOWEVER, THE DISTAL TIP SEPARATED OFF AND FLOATED INTO THE MID RCA. A STENT WAS IMPLANTED, TRAPPING THE TIP TO THE WALL OF THE VESSEL. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18015989 ↗
• MalfunctionJul 27, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. THERE WAS RESISTANCE DURING ADVANCEMENT OF THE NC TREK CATHETER AND THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THE BALLOON RUPTURE WAS CONFIRMED BECAUSE THE CONTRAST AGENT LEAKED. A NEW SAME-SIZED NON-ABBOTT BALLOON DILATATION CATHETER WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED. 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 17410132 ↗
• MalfunctionApr 4, 2023Leak/Splash; Material Rupture; Material Split, Cut or Torn; Leak/Splash; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE THIRD DIAGONAL CORONARY ARTERY WITH INJURY TO 70% OF THE PROXIMAL THIRD, WITHOUT CALCIFICATION AND WITHOUT TORTUOSITY. THE 3.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED AND THE BALLOON WAS NOT HOLDING PRESSURE, INDICATING THAT THE SHAFT WAS PIERCED. THE DEVICE WAS REPLACED. 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 16675562 ↗
• MalfunctionNov 28, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THE DEVICE WAS REMOVED INDEPENDENTLY AND 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 15874708 ↗
• MalfunctionSep 20, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND HEAVY CALCIFICATION. THE 3.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE WITH THE LESION DURING ADVANCEMENT AND RUPTURED AT 12 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE DURING REMOVAL. THE DEVICE WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. 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 15457816 ↗
• MalfunctionApr 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2022, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 99% STENOSED LESION. THE 3.0X8MM NC TREK DILATATION CATHETER WAS UNABLE TO CROSS THE LESION DUE TO ANATOMY. THE DEVICE WAS REMOVED WITH RESISTANCE DUE TO ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. A NON-ABBOTT DEVICE WAS USED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177923 ↗
• MalfunctionNov 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED MID RIGHT CORONARY ARTERY. AFTER AN UNSPECIFIED STENT WAS DEPLOYED, A 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 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 12729008 ↗
• MalfunctionOct 11, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LEFT CIRCUMFLEX CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5X15 NON-ABBOTT BALLOON, AND A 2.5X28MM XIENCE SKYPOINT STENT WAS IMPLANTED. A 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) EXPERIENCED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A 3X8MM 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 12605674 ↗
• MalfunctionOct 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. THE BALLOON OF THE NC TREK WAS INFLATED AT 2 TO 8 ATMOSPHERES GRADUALLY. IT WAS CONFIRMED TO RUPTURE AT 8 ATMOSPHERES DURING THE FIRST INFLATION BY FLUOROGRAPHY. UPON REMOVAL OUTSIDE THE PATIENT, A PINHOLE RUPTURE WAS CONFIRMED. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE WITHOUT INCIDENT. 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 12587038 ↗
• MalfunctionOct 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. REPORTEDLY THE SHAFT OF THE 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) BROKE FROM THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569002 ↗
• MalfunctionSep 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED AND MILDLY TORTUOUS. THE NC TREK WAS ADVANCED TO THE LESION WITHOUT ISSUE, BUT RUPTURED DURING THE SECOND INFLATION AT 16 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530425 ↗
• MalfunctionJul 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 99% STENOSED. THE NC TREK BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE FIRST INFLATION AT 16 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY OF THE PROCEDURE. A NON-ABBOTT NC BALLOON WAS USED TO CONTINUE THE PROCEDURE. THE REPLACEMENT BALLOON INFLATED AT HIGH PRESSURE, THEN A STENT IMPLANTED, AND POST-DILATATION WAS DONE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116554 ↗
• MalfunctionApr 23, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. AFTER STENT DEPLOYMENT, THE NC TREK MET RESISTANCE DURING ADVANCEMENT AND ONCE AT THE STENTED LESION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE NC TREK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11713080 ↗
• MalfunctionMar 11, 2021Material Separation; Failure to Advance; Material Split, Cut or Torn; Material Separation; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER AN UNSPECIFIED STENT WAS IMPLANTED, A 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO THE ANATOMY, AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES. THE BDC WAS SIMPLY WITHDRAWN WITHOUT RESISTANCE. A 2.75X8MM NC TREK BDC ALSO FAILED TO CROSS THE LESION DUE TO THE ANATOMY, AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES. THE BDC WAS SIMPLY WITHDRAWN WITHOUT RESISTANCE. THEN A 2.5X8MM NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: DURING PREP, THE 2.75X8MM NC TREK BALLOON WAS SLIGHTLY INFLATED TO CHECK FOR ANY LEAK. A TEAR IN THE GUIDE WIRE EXIT NOTCH OF THE 3X8MM NC TREK BALLOON WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463132 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX). AFTER STENT IMPLANTATION, A 3X8MM NC TREK CORONARY DILATATION CATHETER WAS ADVANCED TO THE STENT FOR POST-DILATATION. THE BALLOON WAS INFLATED 1 TIME TO 16 ATMOSPHERES (ATM) AND RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263831 ↗
• MalfunctionJan 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, NON-TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11175217 ↗
• MalfunctionSep 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 99% STENOSED. THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE THIRD INFLATION. THE TARGET LESION WAS DILATED ENOUGH; THEREFORE, THE PROCEDURE WAS COMPLETED WITH STENTING. 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 10571168 ↗
• MalfunctionJul 10, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY (DRCA). A 3.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCING WHEN IT MET RESISTANCE WITH AN UNSPECIFIED SOURCE. DEVICE SEPARATED INTO TWO PIECES AT THE SHAFT. DEVICE WAS SIMPLY REMOVED AND ANOTHER UNSPECIFIED BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257554 ↗
• MalfunctionJun 2, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY CALCIFIED, AND MILDLY TORTUOUS DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE AND A LEAK AT THE PROXIMAL SHAFT WAS NOTED. THE BALLOON WAS REMOVED AND A NEW 3.00MM X 8MM NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10112855 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN REMOVING A 3.0X8MM NC TREK FROM THE PACKAGE IT WAS NOTED THAT THE SHAFT WAS SEPARATED IN TWO PIECES. THE CHIPBOARD BOX WAS REPORTED TO NOT HAVE ANY DAMAGE. ANOTHER SAME SIZE NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9954304 ↗
• MalfunctionJan 30, 2020Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  ADDITIONAL INFORMATION: RESISTANCE WAS FELT WITH THE ANATOMY DURING ADVANCEMENT OF THE 3.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC). ADDITIONALLY, RESISTANCE WAS FELT WITH THE ANATOMY DURING REMOVAL AND THE SHAFT SEPARATED. THE SEPARATED BDC WAS WITHDRAWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649029 ↗
• MalfunctionJan 13, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X8MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO POST-DILATE A 3.0X23MM XIENCE XPEDITION STENT HOWEVER, THE NC TREK BALLOON FAILED TO INFLATE AND A LEAK WAS NOTED FROM THE SHAFT. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW SAME SIZE NC TREK 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 9582231 ↗
• MalfunctionMar 28, 2019Loose or Intermittent Connection; Material Separation; Loose or Intermittent Connection; Material Separation

  IT WAS REPORTED THAT THE CONNECTION OF THE INDEFLATOR CAME APART FROM THE SHAFT OF THE 3.0 X 8 MM NC TREK BALLOON DILATATION CATHETER. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. DEVICE ANALYSIS REVEALED THE HYPOTUBE WAS SEPARATED AT THE DISTAL END OF THE HUB. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461968 ↗