NC TREK 1012449-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08717648151880), received between Oct 14, 2016 and Mar 13, 2025 — classified as 1 death, 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF A 3.00X20MM NC TREK BALLOON DILATATION CATHETER, THE PROXIMAL SHAFT WAS NOTED TO BE SEPARATED. ANOTHER NC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599305 ↗
• MalfunctionNov 22, 2024Failure to Fold; Difficult to Remove; Material Separation; Failure to Fold; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE BALLOON DID NOT RE-FOLD TIGHTLY OR UNIFORMLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760903 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE OSTIAL OF THE CIRCUMFLEX. THE 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED HOWEVER DUE TO THE SIGNIFICANT CALCIFICATION IN THE ARTERY, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071291 ↗
• MalfunctionOct 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC), WHEN NEGATIVE PRESSURE WAS APPLIED A LEAK WAS DETECTED. THE BDC WAS NOT USED IN A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER NC TREK BDC WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857608 ↗
• MalfunctionAug 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.0X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE, HOWEVER, THE SHAFT BROKE. THERE WAS NO RESISTANCE DURING REMOVAL AND THE WHOLE DEVICE WAS REMOVED TOGETHER WITH THE GUIDING CATHETER. THE SHAFT WAS NOTED TO BE SEPARATED. 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 17451185 ↗
• 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 17127302 ↗
• MalfunctionApr 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE NC TREK BALLOON DILATATION CATHETER (BDC), AIR APPEARED TO BE PRESENT. THE BALLOON WAS PREPARED PER INSTRUCTIONS FOR USE (IFU), HOWEVER, THERE WAS NO VACUUM BETWEEN BALLOON AND SYRINGE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER NC TREK 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 16762942 ↗
• MalfunctionFeb 9, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. THE VESSEL WAS PREPPED BY ATHERECTOMY AND AN UNSPECIFIED XIENCE STENT WAS IMPLANTED. THE 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 20 ATMOSPHERES. IT WAS NOTED THAT THE BALLOON MAY OF GOTTEN PINCHED BETWEEN THE STENT EDGE AND THE GUIDE LINER THAT WAS BEING USED. NO OTHER DEVICE WAS USED AS THE POST-DILATATION RESULTS WERE GOOD. 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 16342284 ↗
• InjuryDec 5, 2022Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A CSI ATHERECTOMY PROCEDURE AND ATHERECTOMY AND STENTING HAD BEEN PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH STENOSIS AND CALCIFICATION. THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED AND DURING ADVANCEMENT ON THE GUIDE WIRE WITHOUT RESISTANCE, THE SHAFT BECAME KINKED BEFORE ENTERING THE PATIENT. THE DEVICE WAS USED ANYWAY AND DURING ADVANCEMENT THERE WAS SLIGHT RESISTANCE WITH THE ANATOMY AND THE SHAFT SEPARATED. THE PROXIMAL PORTION WAS SIMPLY WITHDRAWN BUT THE DISTAL PORTION WAS REMOVED WHEN IT WAS TRAPPED BY AN ADDITIONAL BDC. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915753 ↗
• InjurySep 2, 2022Inflation Problem; Leak/Splash; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Inflation Problem; Leak/Splash; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED MID CIRCUMFLEX ARTERY. AN NC TREK BALLOON WAS SELECTED FOR POST DILATATION OF A PREVIOUSLY DEPLOYED STENT. THE NC TREK WAS ADVANCED, WITH SOME RESISTANCE NOTICED VIA ANATOMY, BUT WAS STILL ABLE TO CROSS. ONCE THE NC TREK REACHED THE LESION, IT WAS INFLATED ONCE AND CONTRAST LEAKAGE COMING FROM THE SHAFT WAS NOTED. IT WAS DECIDED TO REMOVE THE DEVICE AND WHEN PULLING OUT- THE SHAFT SEPARATED, WITH THE DISTAL PART OF THE SHAFT REMAINING PARTIALLY WITHIN THE GUIDE CATHETER AND THE PROXIMAL SHAFT ABLE TO BE REMOVED. ANOTHER BALLOON WAS INSERTED AND INFLATED BETWEEN THE GUIDE CATHETER AND SEPARATED DISTAL SHAFT OF THE NC TREK TO SECURE IT AND SUCCESSFULLY REMOVE IT WITHOUT ISSUE. A FINAL ANGIOGRAM WAS PERFORMED AND IMAGES WERE GOOD AND NO ISSUES WITH THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352832 ↗
• Mar 30, 2022Material Rupture

  UPON POST DILATATION OF STENT PLACEMENT, NON-COMPLIANT BALLOON RUPTURED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967448 ↗
• MalfunctionNov 4, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3X20MM NC TREK BALLOON MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT AND REMOVAL. ANOTHER DEVICE 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 12753537 ↗
• MalfunctionSep 29, 2021Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED DURING PREPARATION OF THE 3.0X20MM NC TREK BALLOON DILATATION CATHETER, THE PROXIMAL SHAFT WAS KINKED. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. PER DEVICE ANALYSIS THE HYPOTUBE WAS SEPARATED 5MM PROXIMAL TO THE STRAIN RELIEF DISTAL END. THE ACCOUNT COULD NOT CONFIRM WHEN THE SEPARATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547655 ↗
• MalfunctionAug 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.0X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO PRE-DILATE THE LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298261 ↗
• MalfunctionJun 30, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 85% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE 3.0X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS INFLATED TO 12 ATMOSPHERES; HOWEVER, IT DEFLATED AND WOULD NO LONGER INFLATE. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT ANATOMY AND ONCE OUTSIDE IT WAS TESTED ON THE BACK TABLE AND A LEAK IN THE DISTAL SHAFT WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X20MM NC TREK BDC. 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 12097330 ↗
• MalfunctionOct 27, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE DEVICE WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS MILDLY CALCIFIED. THE NC TREK RX BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND 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 Consequences Or Impact To Patient

  MAUDE report 10744533 ↗
• MalfunctionDec 20, 2019Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TREATING THE PROXIMAL LEFT CIRCUMFLEX (CX) LESION. AN UNSPECIFIED STENT WAS IMPLANTED IN THE PROXIMAL CX. POST-DILATATION WAS PERFORMED USING AN NC TREK FOR TWO INFLATIONS (10 ATMS FOR 11 SECONDS, 10 ATMS FOR 20 SECONDS) WITHOUT ISSUES. AFTER THE THIRD INFLATION (15 ATMS FOR 12 SECONDS), THE BALLOON WAS UNABLE TO DEFLATE. NEGATIVE WAS PULLED GREATER THAN 30 SECONDS AND THE BALLOON PARTIALLY DEFLATED. THE NC TREK WAS RETRACTED INTO THE GUIDE CATHETER AND ALL (GUIDE CATHETER, NC TREK, GUIDEWIRE) WAS REMOVED AS A SINGLE UNIT. ONCE OUTSIDE THE ANATOMY, THE NC TREK WAS UNABLE TO BE REMOVED FROM THE GUIDE CATHETER. THERE WAS NO DAMAGE NOTED TO THE IMPLANTED STENT AND NO DAMAGE TO THE VESSEL. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9500970 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS DONE USING THE 3.0X20MM NC TREK BALLOON AND A DISSECTION OCCURRED. A XIENCE STENT WAS USED TO COVER THE DISSECTION AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 9257514 ↗
• MalfunctionOct 28, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION AND MODERATE TORTUOSITY IN THE RIGHT CORONARY ARTERY. THE NC TREK BALLOON CATHETER MET RESISTANCE WITH THE COPILOT DURING ADVANCEMENT WHICH CAUSED THE HYPOTUBE TO BREAK IN TWO PIECES. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE AS THE DISTAL END OF THE BALLOON CATHETER WAS IN THE PROXIMAL END OF THE GUIDING CATHETER AND WAS ABLE TO BE REMOVED. A NEW BALLOON CATHETER WAS USED WITH THE SAME COPILOT SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247095 ↗
• MalfunctionOct 24, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3X20MM NC TREK BALLOON DILATATION CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE AND WAS ATTEMPTED TWICE TO INFLATE TO 15 ATM BUT COMPLETELY FAILED TO INFLATE, DUE TO A HOLE THAT WAS NOTED ON THE BALLOON DURING INFLATION. AN UNSPECIFIED NC TREK 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 9233403 ↗
• MalfunctionOct 11, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED CAROTID ARTERY THAT WAS 70% STENOSED. A 3X20MM NC TREK BALLOON DILATATION CATHETER WAS USED TO PRE-DILATE THE LESION. THE BALLOON WAS COMPLETELY DEFLATED. DURING REMOVAL, THE BALLOON COULD NOT BE REMOVED WITHOUT ALSO REMOVING THE HI-TORQURE COMMAND 14 ES GUIDE WIRE WITH IT. THE BALLOON SEEMED TO BE STUCK TO THE GUIDE WIRE. THEY WERE SIMPLY REMOVED TOGETHER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182812 ↗
• MalfunctionAug 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. A 3.0 X 20 MM NC TREK BALLOON CATHETER WAS USED; HOWEVER, THE DEVICE SEPARATED WHEN IT WAS REMOVED FROM THE ANATOMY. THEREFORE, AN UNSPECIFIED DEVICE 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 8851115 ↗
• MalfunctionJul 10, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING UNPACKAGING, THE LABEL IN THE POUCH DID NOT MATCH THE CHIPBOARD BOX: THE POUCH WAS LABELED AS A 3.0X15MM RX NC TREK WHILE THE CHIPBOARD BOX WAS LABELED AS A 3.0X20MM RX NC TREK. THE DEVICE WAS NOT USED. 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 8777666 ↗
• DeathMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION OF THE ARTERY A NON-ABBOTT ATHERECTOMY SYSTEM WAS USED AND FOLLOWED BY PRE-DILATATION WITH A 3.0X20MM NC TREK BALLOON DILATATION CATHETER; HOWEVER, A PERFORATION WAS NOTED. THE PERFORATION CAUSED A PERICARDIAL EFFUSION WHICH RESULTED IN CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED; HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 8597008 ↗
• MalfunctionFeb 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY, A 3.0X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST STENT DILATATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 16 ATMOSPHERES. THE BDC WAS REPLACED WITH A NEW NC TREK BDC TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318551 ↗