NC TREK™ 1012454-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08717648152115), received between Oct 27, 2016 and Feb 20, 2024 — classified as 15 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (41 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 29, 2020Terminated

   Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

   Z-1134-2020 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 65% STENOSED LESION IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE FOR DILATATION AND THE TIP OF THE BALLOON BROKE OFF IN THE VESSEL. A SNARE DEVICE WAS USED TO ATTEMPT TO REMOVE THE SEPARATED PORTION OF THE BDC; HOWEVER, COULD NOT BE REMOVED. THE PATIENT WAS TRANSFERRED TO VASCULAR SURGERY AND THE SEPARATED PORTION OF THE BDC WAS REMOVED IN SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743739 ↗
• InjuryOct 27, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT WAS ADMITTED FOR DELAYED ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) WITH ISCHEMIC CARDIOMYOPATHY AND MULTI-VESSEL CORONARY ARTERY DISEASE (CAD) WAS OBSERVED; HOWEVER, NOT A CANDIDATE FOR CORONARY ARTERY BYPASS GRAFT (CABG). IT WAS NOTED EARLIER THAT DAY THE PATIENT HAD AN UNSPECIFIED STENT IMPLANTED. HOWEVER, COMPLICATIONS AROUSE AND THE PATIENT WAS BROUGHT BACK. A PERFORATION WAS OBSERVED AND A UNSPECIFIED COVERED STENT WAS USED. THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED TWICE TO 20 ATMOSPHERES FOR 12 SECONDS. DURING REMOVAL OF THE BDC, RESISTANCE WITH FELT AND IT WAS OBSERVED THAT THE TIP OF THE BDC SEPARATED. IT WAS ATTEMPTED TO SNARE THE SEPARATED TIP. HOWEVER, IT WAS UNSUCCESSFUL. THE PATIENT DIED DUE TO CARDIOGENIC SHOCK. PER THE PHYSICIAN'S OPINION, THE NC TREK DID NOT CAUSE OR CONTRIBUTE TO PATIENT'S DEATH. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18023846 ↗
• MalfunctionAug 23, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.5X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION AFTER ANGIOGRAPHIC FINDINGS SHOWED SUBACUTE THROMBOSIS IN THE LEFT MAIN (LM)-LAD STENT AND POOR EXPANSION OF THE LM TAIL. THE GUIDING CATHETER AND SHEATH GOT STUCK WHEN THE SHEATH WAS RETRACTED SO THE GUIDING CATHETER AND SHEATH WERE WITHDRAWN TOGETHER. THE BALLOON WAS SIMPLY WITHDRAWN AND THE SHAFT WAS NOTED TO BE BENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606812 ↗
• MalfunctionAug 18, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC); HOWEVER, DURING RETRACTION, RESISTANCE WAS NOTED WITH THE GUIDE CATHETER. FORCE WAS APPLIED AND THE SHAFT SEPARATED, BUT THE BDC WAS ABLE TO BE REMOVED WITHOUT ISSUE. ANOTHER SAME SIZE NC TREK BDC WAS USED IN 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 17573579 ↗
• InjuryAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH 90% STENOSIS. A 4.0X28MM XIENCE SIERRA STENT WAS IMPLANTED AND A 4.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, DURING REMOVAL, THE BALLOON SEPARATED AT THE MAIN SHAFT. THE SEPARATED PORTION REMAINED IN THE STENT. ANGIOGRAPHY CONFIRMED THAT THE PATIENT DEVELOPED ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A 7MM SNARE DEVICE WAS USED TO RETRIEVE THE BALLOON SUCCESSFULLY WITHOUT RESISTANCE. THERE WAS ADVERSE PATIENT SEQUELA; HOWEVER, A 10 MIN DELAY IN THE PROCEDURE WHICH REPORTEDLY CONTRIBUTED TO THE STEMI. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 17515598 ↗
• MalfunctionJul 21, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MAIN TRUNK TO ANTERIOR DESCENDING PROXIMAL THIRD ARTERY. THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, AFTER DEFLATING THE BALLOON, DURING REMOVAL THE BDC BECAME STUCK WITH A 7F GUIDE CATHETER (GC) AND WAS NOT ABLE TO ENTER THE GC. AFTER, MANIPULATION THE BDC WAS ABLE TO ENTER THE GC WITH DIFFICULTY AND THE BDC HAD TO BE REMOVED WITH THE GC AS A SINGLE UNIT. 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 17373920 ↗
• InjuryJul 17, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4.5X15MM NC TREK RX BALLOON RUPTURED IN THE RCA OSTIUM AND WAS NOTED TO HAVE SEPARATED. THE SEPARATED PORTION COULD NOT BE REMOVED FROM THE ANATOMY. THE PATIENT HAD TO BE TRANSFERRED TO CARDIAC SURGERY AS AN EMERGENCY AND HAD A VERY DIFFICULT COURSE WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE WAS PROLONGED INTENSIVE CARE STAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17336603 ↗
• InjuryJul 11, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT AN UNSPECIFIED LESION. THE 4.5 X 15 MM NC TREK BALLOON CATHETER WAS ADVANCED AND IT WAS NOTED THAT THERE WAS RESISTANCE WITH THE GUIDE CATHETER DURING POST DILATATION, AND THE BALLOON CATHETER BROKE INSIDE THE PATIENT ANATOMY. THE SEPARATED PORTION WAS RETRIEVED VIA SNARE DEVICE AND THERE WAS NO PORTION LEFT INSIDE THE PATIENT ANATOMY. 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 17299493 ↗
• MalfunctionJun 21, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 70% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 4.50X15MM NC TREK OVER THE WIRE (OTW) BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE (GW) WITH RESISTANCE MET WITH THE GW. THE BDC WAS ABLE TO MAKE IT TO PART OF THE LESION AND WAS USED FOR DILATATION, HOWEVER THE NC TREK BDC COULD NOT BE FURTHER ADVANCED TO COMPLETE DILATATION DUE TO THE RESISTANCE MET WITH THE GUIDE WIRE. UPON REMOVAL OF THE BDC, RESISTANCE WAS MET AGAIN WITH THE GUIDE WIRE. A NEW NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175152 ↗
• MalfunctionMay 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) WITH HEAVY CALCIFICATION. THE 4.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE FOR POST DILATATION; HOWEVER, DURING REMOVAL OF THE BDC THE CATHETER WAS NOT ABLE TO BE PULLED INTO THE GUIDE CATHETER. THEREFORE, THE BDC HAD TO BE REMOVED WITH THE GUIDE CATHETER AND GUIDEWIRE AS A SINGLE UNIT. 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 16963979 ↗
• MalfunctionApr 14, 2023Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A NON-ABBOTT STENT WAS IMPLANTED AND DUE TO POOR APPOSITION, THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE DEVICE WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE CONTRAST MIX WAS 1:1 SALINE AND CONTRAST. THE BALLOON WAS INFLATED TWICE TO 16 ATMOSPHERES (ATMS) FOR 6 SECONDS. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE BALLOON DID NOT FULLY DEFLATE AND IT WAS DIFFICULT TO RETRACT INTO THE 7FRENCH (FR) GUIDE CATHETER. AFTER PULLING NEGATIVE PRESSURE REPEATEDLY WITH THE INDEFLATOR, FORCE WAS APPLIED TO PULL THE BALLOON CATHETER INTO THE 7F GUIDE CATHETER. THE BALLOON CATHETER WAS REMOVED INDEPENDENTLY PARTIALLY DEFLATED AND THE SHAFT WAS FOUND TO BE BENT. 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 16742991 ↗
• MalfunctionApr 5, 2023Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED AND DEFLATED WITHOUT ISSUE; HOWEVER, IT WAS NOTED THAT THE BALLOON FAILED TO FOLD BACK PROPERLY LOOKED BUNCHED ONCE REMOVED. DURING REMOVAL THERE WAS RESISTANCE WITH THE UNSPECIFIED GUIDE CATHETER AS THE BALLOON DIDN'T FOLD CORRECTLY AND BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. AS THE PROCEDURE WAS ALREADY COMPLETE NO OTHER DEVICE WAS USED. 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 16686311 ↗
• MalfunctionDec 6, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL CORONARY ARTERY. AN NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED INTO A GUIDE CATHETER (GC), WHEN STRONG RESISTANCE WAS MET BETWEEN THE BDC AND THE GC, CAUSING THE SHAFT OF THE BDC TO BECOME SEPARATED INSIDE OF THE GUIDE CATHETER. THE BDC AND ALL SEPARATED PIECES WERE SIMPLY REMOVED WITHOUT ISSUE; NO SNARE WAS REQUIRED, AND NO MATERIAL WAS LEFT IN THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926057 ↗
• InjuryOct 5, 2022Failure to Fold; Off-Label Use; Difficult to Remove; Material Separation; Failure to Fold; Off-Label Use; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIAL ARTERY. AN EMBOSHIELD NAV6 FILTER WAS ADVANCED WITHOUT ISSUES. A 4.5X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE NAV6 WIRE TO POST-DILATE AN UNSPECIFIED DEPLOYED STENT; HOWEVER, THE BALLOON DID NOT REWRAP WELL AND COULD NOT BE REMOVED DUE TO RESISTANCE WITH THE ANATOMY. THERE WAS NO DEFLATION ISSUE. WHILE ATTEMPTING TO REMOVE THE BDC THE SHAFT SEPARATED. AN ASPIRATION CATHETER WAS ADVANCED TO HELP REMOVE THE SEPARATED BDC. THE SEPARATED BDC WAS SUCCESSFULLY REMOVED WITH THE ASPIRATION CATHETER AND NAV6 FILTER. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547504 ↗
• MalfunctionAug 30, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION. THE 4.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATION OF A 4.0X23 MM XIENCE STENT AND INFLATED ONCE AT NOMINAL PRESSURE. AFTER POST DILATION WAS PERFORMED, NEGATIVE WAS PULLED AND HELD THE ENTIRE TIME THE BALLOON WAS BEING WITHDRAWN BUT IT WAS NOTED THERE WAS RESISTANCE WHEN PULLING THE NC TREK BDC BACK INTO THE GUIDING CATHETER. IT WAS THEN OBSERVED THAT ROUGHLY 10-15CM OF THE BDC HAD DETACHED. THE BALLOON WAS NOTED TO NOT BE FULLY DEFLATED UPON REMOVAL AS IT WAS PULLED A LITTLE BEFORE FULL DEFLATION. THE DETACHED PORTION REMAINED IN THE GUIDING CATHETER AND WAS ABLE TO BE REMOVED WITHOUT FURTHER ISSUES. THE XIENCE STENT WAS CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. 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 15322704 ↗
• MalfunctionJul 26, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 4.5X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT. THERE WAS RESISTANCE DURING WITHDRAWAL DUE TO THE ANATOMY AND FORCE WAS APPLIED BUT NOT EXCESSIVELY; HOWEVER, THE SHAFT SEPARATED APPROXIMATELY 15 CM FROM THE TIP INSIDE THE GUIDING CATHETER. THE SEPARATED PART WAS CAUGHT INSIDE THE GUIDING CATHETER AND SIMPLY WITHDRAWN. THERE WAS NO REPORTED 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 15107709 ↗
• MalfunctionApr 14, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION; HOWEVER, WHEN ATTEMPTING TO REMOVE THE BDC IT BECAME STUCK WITH THE GUIDING CATHETER. AFTER SOME TIME IT WAS ABLE TO RELEASE AND ATTEMPTED TO BE REMOVED AGAIN HOWEVER, THE BDC BECAME STUCK WITH THE SHEATH. THEREFORE, THE ENTIRE SYSTEM WAS REMOVED AS AN ENTIRE UNIT INCLUDING THE GUIDING CATHETER. NO OTHER DEVICE WAS USED AS POST DILATATION WAS COMPLETED WITH THE NC TREK. 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 14115268 ↗
• InjuryApr 14, 2022Deflation 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 THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA). THE 4.5X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 20 ATMOSPHERES (ATM) FOR POST DILATATION AND THEN IT COULD NOT DEFLATE AND ONLY PARTIALLY DEFLATED. NEGATIVE WAS HELD MANY TIMES AND THE CONTRAST MIX WAS 3:1. MULTIPLE SYRINGES WERE EXCHANGED AND MANUAL DEFLATION WOULD NOT WORK. ULTIMATELY THE DEVICE WAS DELIBERATELY BROKEN IN THE AORTA TO BE ABLE TO RE-INTRODUCE IT INTO THE CATHETER TO BE REMOVED. THERE WERE NO REPORTED PATIENT SEQUELA 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 14113053 ↗
• InjuryMar 8, 2022Off-Label Use; Material Separation; Difficult to Advance; Off-Label Use; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT LEG TIBIAL ARTERY. A 4.5 X 15 MM NC TREK BALLOON CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE DUE TO THE ANATOMY AND THEN IT WAS NOTED THAT THE BALLOON HAD COMPLETELY SEPARATED AT THE LESION. THE BALLOON WAS ABLE TO BE STENTED AGAINST THE DISEASED VESSEL. THERE WAS NO ADDITIONAL ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13694720 ↗
• InjuryFeb 21, 2022Failure to Fold; Difficult to Remove; Material Separation; Failure to Fold; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED OSTIAL RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, WITH A 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC), POST-DILATATION WAS COMPLETED AND DURING REMOVAL OF THE BDC FROM THE ANATOMY, THE HYPOTUBE BROKE INTO TWO PARTS. IT WAS SUSPECTED THAT THE BALLOON MAY NOT HAVE FOLDED WELL AND COULD NOT BE RETRACTED BACK INTO THE 6FR GUIDE CATHETER, AND WHEN RESISTANCE WAS MET DURING RETRACTION, THE SHAFT SEPARATED. A NEW GUIDE CATHETER AND A SECOND BALLOON WERE USED TO TRAP THE SEPARATED PIECE IN THE CATHETER AND RETRACT IT INTO THE INTRODUCER SHEATH, TO REMOVE IT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573082 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 4.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND SUCCESSFULLY DILATATED THE LESION. UPON REMOVAL, THE BDC WAS DIFFICULT TO REMOVE FROM THE GUIDING CATHETER AND THE DELIVERY SYSTEM AND GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. 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 13161860 ↗
• MalfunctionDec 20, 2021Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY. A 4.50 X 15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. HOWEVER, AFTER THE FINAL INFLATION WAS COMPLETED, THE BALLOON COULD ONLY PARTIALLY DEFLATE. AN ATTEMPT WAS MADE TO RETRACT THE BDC INTO THE GUIDING CATHETER WHEN THE BALLOON BECAME STUCK AND SEPARATED. THE SEPARATED PORTION OF THE BALLOON REMAINED WEDGED INSIDE THE GUIDING CATHETER. THEREFORE, THE BDC WAS REMOVED WITH THE GUIDING CATHETER AND THE SEPARATED PORTION AS A SINGLE UNIT. THE PROCEDURE CONTINUED WITH A NEW BDC AND NEW GUIDING CATHETER 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 13044011 ↗
• MalfunctionJul 28, 2021Deflation Problem; Failure to Fold; Difficult to Remove; Material Separation; Material Deformation; Deflation Problem; Failure to Fold; Difficult to Remove; Material Separation; Material Deformation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE DEVICE WAS NOT REPOSITIONED DURING THE FIRST TWO INFLATIONS/DEFLATIONS. THE DEFLATION ISSUE WAS ONLY NOTED DURING THE THIRD INFLATION. THE DISTAL END OF THE BALLOON MATERIAL BUNCHED UP RESULTING IN THE BALLOON BEING STUCK AT THE TIP OF THE GUIDING CATHETER. THERE WAS NO FLARED TIP. THE HYPOTUBE WAS SEPARATED DURING PREPARATION FOR SHIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242966 ↗
• MalfunctionJun 23, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED. THE NC TREK WAS ADVANCED TO THE LESION. AFTER THE SECOND INFLATION AT 15 ATMOSPHERES (ATM), THE BALLOON ONLY MINIMALLY DEFLATED. TROUBLESHOOTING TO DEFLATE THE BALLOON WAS UNSUCCESSFUL, SO THE DEVICE WAS REMOVED WITH THE SHEATH AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053304 ↗
• MalfunctionMay 12, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THREE UNSPECIFIED STENTS WERE DEPLOYED AND A 4.5X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE FOR POST-DILATATION. THE BDC WAS BEING REMOVED; HOWEVER, RESISTANCE WAS FELT WITH THE 6F GUIDE CATHETER AND THE BDC WOULD NOT GO BACK INTO THE GUIDE CATHETER. THE BDC AND GUIDE CATHETER HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THAT TIME. 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 11815773 ↗