NC TREK 1012451-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 08717648151972), received between Oct 6, 2016 and Feb 9, 2026 — classified as 7 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (43 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH 90% STENOSIS. A DRUG ELUTING STENT WAS IMPLANTED AND THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BACKLOADED ONO THE GUIDE WIRE THROUGH THE GUIDING CATHETER WHEN BLOOD WAS NOTED INSIDE THE INFLATION DEVICE. A LEAK WAS SUSPECTED IN THE BALLOON/SHAFT SO THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 24292169 ↗
• MalfunctionNov 22, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 88% STENOSED LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 20765200 ↗
• InjuryAug 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 70% STENOSED, DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE, A 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION. UPON INFLATION OF THE BALLOON, THERE WAS NO BALLOON RUPTURE OR RE-FLOW, HOWEVER, AIR AND CONTRAST WERE LEAKING FROM THE TIP OF THE BALLOON CATHETER, INTO THE CORONARY ARTERY. THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF), RESULTING IN REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). AT THE END OF THE PROCEDURE, THE PATIENT WAS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 17502259 ↗
• InjuryJul 5, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED, HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED AND DEFLATED SUCCESSFULLY. DURING REMOVAL, RESISTANCE WAS NOTED AND THE SHAFT SEPARATED AND REMAINED IN THE ANATOMY. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED PORTION, BUT WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR OPEN HEART SURGERY AT A DIFFERENT HOSPITAL. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 17262758 ↗
• MalfunctionJun 14, 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 LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY THAT WAS 60% STENOSED. REPORTEDLY, THE NC TREK RX 3.50 X 12MM BALLOON RUPTURED IN THE PATIENT DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE DEVICE WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH A NEW SAME SIZE BALLOON. 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 17126096 ↗
• MalfunctionJun 5, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY THAT IS 80% STENOSED. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED IN THE ANATOMY 7-8 TIME TO 13 ATMOSPHERES; HOWEVER, WHEN ATTEMPTING TO DEFLATE THE BDC, IT WOULD NOT DEFLATE FULLY. NEGATIVE PRESSURE WAS PULLED REPEATEDLY, HOWEVER, THE BDC WOULD NOT DEFLATE FULLY. THE BDC WAS VIGOROUSLY PULLED OUT THE PATIENT ANATOMY MEETING RESISTANCE DURING REMOVAL WITH ANATOMY, GUIDE WIRE, AND GUIDE CATHETER. THE BDC NOTED TO STILL BE FILED WITH CONTRAST. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059803 ↗
• MalfunctionApr 23, 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 LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ISSUES. THE BALLOON WAS ADVANCED WITHOUT RESISTANCE AND INFLATED TWICE ABOVE THE RATED BURST PRESSURE (RBP). THE BALLOON RUPTURED. 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 16792923 ↗
• MalfunctionNov 9, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY, AND 99% STENOSIS. THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND WAS USED FOR PRE-DILATATION. THE BALLOON RUPTURED AT 12 ATMOSPHERES ON THE FIRST INFLATION FOR 15 SECONDS. A XIENCE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762951 ↗
• MalfunctionNov 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, NON-TORTUOUS PROXIMAL RIGHT CORONARY ARTERY WITH 90% STENOSIS. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) AND A NON-ABBOTT STENT WAS IMPLANTED. THE 3.5X12 MM NC TREK BDC WAS USED FOR POST-DILATATION BUT RUPTURED ON THE FIRST INFLATION TO 12 ATMOSPHERES FOR 10 SECONDS. A NON-ABBOTT BDC 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 15757117 ↗
• MalfunctionOct 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS DE NOVO RIGHT CORONARY ARTERY THAT IS 70% STENOSED. A NON-ABBOTT GUIDE WIRE WAS ADVANCED A 3.0X18MM NON-ABBOTT BALLOON WAS USED TO PREDILATE THE LESION. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER WAS ALSO ADVANCED AND INFLATED TO PRE-DILATE THE LESION; HOWEVER, RUPTURED AT 14 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 15640628 ↗
• MalfunctionOct 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND NO TORTUOSITY, WITH IN STENT RESTENOSIS. THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND ADVANCED WITHOUT RESISTANCE. THE BALLOON WAS INFLATED ONCE TO 13 ATMOSPHERES (ATM) FOR 10 SECONDS AND RUPTURED. A NON-ABBOTT BDC 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 15577453 ↗
• MalfunctionOct 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS NON CALCIFIED AND NON TORTUOUS. THE LESION WAS PRE DILATED WITH AN 2.5X12 NC TREK AND A 3.5 X 38 XIENCE SKYPOINT WAS DEPLOYED. POST DILATATION WAS ATTEMPTED WITH THE NC TREK; HOWEVER, THE GUIDE WIRE MET RESISTANCE COMING OUT OF NC TREK AT THE TIP OF THE CATHETER. THE ENTIRE UNIT WAS PULLED INTO THE GUIDE CATHETER, BUT THE GUIDE WIRE SPLIT THE RAPID EXCHANGE PORT ON THE CATHETER. ALL WAS SUCCESSFULLY RETRIEVED WITH NO INTERVENTION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE LESION WAS RE-WIRED WITH A NON-ABBOTT GUIDE WIRE AND A NEW NC TREK WAS ADVANCED TO POST-DILATE THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547132 ↗
• MalfunctionSep 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, 90% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). AFTER A NON-ABBOTT STENT WAS IMPLANTED, A 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED, WITHOUT ISSUE, TO POST-DILATATE THE POORLY EXPANDED STENT. DURING THE FIRST INFLATION TO 14 ATMOSPHERES (ATM) WHICH WAS HELD FOR 10 SECONDS, 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 DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341157 ↗
• MalfunctionAug 30, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE 3.50 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC), MET RESISTANCE DURING ADVANCEMENT INTO THE GUIDE CATHETER AND THE SHAFT SEPARATED INSIDE THE GUIDE CATHETER. THE SEPARATED SEGMENT WAS IN THE GUIDE CATHETER AND WAS STILL ON THE GUIDE WIRE. THE DEVICES WERE REMOVED AS A SINGLE UNIT. A NEW NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321215 ↗
• MalfunctionAug 23, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TWICE AND RUPTURED AT 15 ATMOSPHERES (ATM). 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 15277125 ↗
• MalfunctionJul 27, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.5X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE LESION DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION AND STENT DISLODGEMENT. THE BDC WAS REMOVED INDEPENDENTLY. THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117759 ↗
• MalfunctionJul 13, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FROM THE ANATOMY AND INFLATED ONCE TO 7 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND A 3.25MM CUTTING 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 15009512 ↗
• MalfunctionJul 1, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  T WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MILDLY CALCIFIED VESSEL WITHOUT TORTUOSITY IN THE MID RIGHT CORONARY ARTERY (MRCA). AFTER A 3.5MM DRUG ELUTING STENT WAS DEPLOYED IN THE MRCA, THERE WAS MALAPPOSITION AT THE PROXIMAL EDGE. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12ATM FOR 10 SECONDS. PRIOR TO USE, THE CATHETER WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) INSIDE THE ANATOMY. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. THERE WAS RESISTANCE WITH A GUIDE CATHETER DURING REMOVAL. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. 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 14886425 ↗
• MalfunctionJun 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE MID RIGHT CORONARY ARTERY (MRCA). THE 3.5X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS USED FOR POST DILATATION. THE BDC WAS INFLATED TWICE. FIRST INFLATION WAS AT 12 ATMOSPHERES (ATMS) FOR 10 SECONDS, HOWEVER, THE BDC RUPTURED ON THE SECOND INFLATION AT 18 ATMS. IT WAS NOTED THAT THE STRUT OF THE POORLY DEPLOYED STENT POSSIBLY CAUGHT THE BALLOON. THERE WAS NO RESISTANCE DURING REMOVAL. THE 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 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 14670875 ↗
• MalfunctionMay 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS UNABLE TO HOLD AIR DURING PREPARATION OUTSIDE THE ANATOMY. THE LEAK WAS OBSERVED AS THERE WERE AIR BUBBLES DURING ASPIRATION. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14372827 ↗
• MalfunctionMay 5, 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 A 70% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED, AIR ASPIRATED, IN THE VESSEL, THEN ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION FOR 20 SECONDS AT 18 ATMOSPHERES (ATM). THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. A 3.5X20MM NON-ABBOTT DRUG COATED BALLOON (DCB) WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291925 ↗
• MalfunctionApr 22, 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 HEAVILY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY THAT IS 90% STENOSED. THE 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. RESISTANCE DURING ADVANCEMENT AND RESISTANCE DURING REMOVAL OF THE BDC WAS MET WITH ANATOMY. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187999 ↗
• MalfunctionApr 20, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 100% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 3.5X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THE BDC WAS REMOVED INDEPENDENTLY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION OR STENT DISLODGMENT. A NON-ABBOTT BDC 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 14162213 ↗
• MalfunctionMar 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A 4.00 X 15MM XIENCE SKYPOINT DES RX FAILED TO CROSS THE LESION DUE TO THE ANATOMY. A NON-ABBOTT STENT CROSSED WITHOUT ISSUE. DURING ADVANCEMENT OF A 3.50 X 12MM NC TREK THROUGH THE GUIDE CATHETER FOR POST DILATATION, THE PROXIMAL SHAFT SEPARATED IN TWO, BUT WAS EASILY REMOVED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. THERE WAS NO REPORTED 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 13971362 ↗
• MalfunctionJan 20, 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 A RESTENOSED NON-TORTUOUS, NON-CALCIFIED PROXIMAL RIGHT CORONARY ARTERY THAT WAS 75% STENOSED. A 3.5X12MM NC TREK BALLOON DELIVERY CATHETER (BDC) WAS DELIVERED WITHOUT RESISTANCE AND INFLATED ONCE AT 14 ATMOSPHERES, HOWEVER, THE BALLOON RUPTURED. THEN A NON-ABBOTT NC BDC WAS USED AND COMPLETED DILATING WITHOUT ISSUE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT ADVERSE EVENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311268 ↗