NC TREK™ 1012454-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08717648152122), received between Apr 25, 2017 and Feb 5, 2025 — classified as 2 deaths, 10 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (25 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 29, 2020Terminated

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

   Z-1135-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 4.50X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 16 ATMOSPHERES. DURING REMOVAL RESISTANCE WAS MET WITH THE 6FR GUIDING CATHETER AND THE BALLOON APPEARED DEFORMED. THE BDC, GUIDING CATHETER, AND GUIDE WIRE HAD TO BE REMOVED AS ONE UNIT. 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 21313981 ↗
• InjuryJan 29, 2025Difficult 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 THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90-100% STENOSIS. THE 4.5X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED THREE TIMES BETWEEN 14-18 ATMOSPHERES. NEGATIVE PRESSURE WAS HELD FOR 3 SECONDS AND THE BALLOON WAS FULLY DEFLATED UPON REMOVAL; HOWEVER, THE BALLOON WAS STUCK WITH THE GUIDE WIRE. ALL OF THE DEVICES WERE REMOVED TOGETHER AS A UNIT, CAUSING WIRE ACCESS TO BE LOST. THERE WAS A SLIGHT DELAY IN THE PROCEDURE AND THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND THROMBOSIS OCCURRED IN THE RCA CONFIRMED WITH ANGIOGRAPHY. MEDICATION WAS GIVEN FOR THE THROMBOSIS. A 5.0X15 MM NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE AND A STENT WAS PLACED SUCCESSFULLY. THE PATIENT WAS HOSPITALIZED AND THE HEMODYNAMICS ARE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED COLOMBIA REPORT IT WAS REPORTED THE BALLOON WAS INFLATED 3 TIMES BETWEEN 14-18 ATMOSPHERES AND NEGATIVE WAS HELD FOR 3 SECONDS. THE BALLOON WAS FULLY DEFLATED UPON REMOVAL. MEDICATION WAS GIVEN FOR THE THROMBOSIS WHICH WAS CONFIRMED WITH ANGIOGRAPHY. NO ADDITIONAL INFORMATION WAS PROVID

  Patient problems: Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 21269631 ↗
• InjuryOct 23, 2024Deflation 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 PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) OSTIUM WITH MILD CALCIFICATION, NO TORTUOSITY AND 70% STENOSIS. AN UNSPECIFIED STENT WAS IMPLANTED AND POST DILATION WAS PERFORMED BY THE 4.5X20MM NON-COMPLIANT (NC) TREK BALLOON DILATATION CATHETER (BDC). THE BALLOON WAS INFLATED TWICE TO 16 ATMOSPHERES (ATM). UPON DEFLATION, THE DEVICE WAS HELD NEGATIVE FOR A NORMAL AMOUNT OF TIME; HOWEVER, THE BALLOON ONLY DEFLATED ABOUT 20% AND REMAINED STUCK IN THE CORONARY ARTERY. TWO ATTEMPTS TO DEFLATE THE BALLOON WITH TWO DIFFERENT NON-ABBOTT INFLATION DEVICE, BEFORE RESORTING TO MANUAL DEFLATION WITH A SYRINGE. THE PATIENT EXPERIENCED A TEMPORARY INFERIOR ST ELEVATION WHICH RESOLVED ITSELF UPON DEVICE REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20516620 ↗
• DeathAug 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 4.5X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED. THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT AND EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19999915 ↗
• MalfunctionJun 27, 2024Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ADVANCE A 4.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) IT WOULD NOT ADVANCE. DURING REMOVAL THE BDC MET RESISTANCE WITH THE .014 BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE. IT WAS NOTED THAT BOTH DEVICES HAD TO BE REMOVED TOGETHER AS ONE UNIT. ON THE GUIDE WIRE A SMALL RELIEF [UNKNOWN DAMAGE] WAS OBSERVED JUST BEFORE THE BEGINNING OF THE RADIOPAQUE MARK AND THE SHAFT OF THE BDC WAS NOTED TO BE DAMAGED. ANOTHER GUIDE WIRE AND BALLOON WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19628037 ↗
• InjurySep 25, 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 PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). AFTER PREDILATING THE LESION WITH A 4.50X20MM NC TREK BALLOON DILATATION CATHETER (BDC), THE BALLOON WAS DEFLATED AND DURING REMOVAL BECAME STUCK DUE TO THE ANATOMY. DURING REMOVAL, PRESSURE WAS APPLIED AND A SEPARATION OCCURRED. A NON-ABBOTT SLING [SNARE] WAS USED TO REMOVE THE BALLOON. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 2 HOUR DELAY IN THE PROCEDURE; HOWEVER, THERE WERE NO ADVERSE PATIENT SEQUELA. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812803 ↗
• DeathJul 20, 2023Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT MAIN (LM) TO THE LEFT CIRCUMFLEX (CX) ARTERY. IT WAS NOTED THAT THE PATIENT HAD MANY COMORBODITIES AND WAS PREVIOUSLY TURNED DOWN FOR PCI. AN UNSPECIFIED STENT WAS IMPLANTED AND THE 4.50X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE STENT FOR POST DILATATION. THE BALLOON WAS INFLATED TWICE TO 18 ATMOSPHERES (ATM). AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON; HOWEVER, IT WOULD NOT FULLY DEFLATE. IT WAS THOUGHT THAT THE NC TREK BALLOON WAS STUCK ON A STENT STRUT OR ON CALCIUM. THE NC TREK WAS TUGGED WITH FORCE, BUT THE BALLOON SEPARATED FROM THE DELIVERY SYSTEM IN EITHER THE LM OR THE CX. AN ATTEMPTED WAS MADE TO SNARE OUT THE BALLOON BUT IT COULD NOT BE REMOVED. THE SEPARATED BALLOON WAS BLOCKING THE BLOOD FLOW AND THE PATIENT¿S BLOOD PRESSURE WAS DROPPING; THEREFORE, AN IMPELLA HEART PUMP WAS PLACED. A VASCULAR SURGEON WAS CONSULTED; HOWEVER, THE PATIENT WAS NOT A CANDIDATE FOR SURGERY DUE TO THE PRIOR CORONARY ARTERY BYPASS GRAFT (CABG) AND HIS HEALTH DECOMPENSATED. THE PATIENT EXPIRED ON 6/14/2023, SAME DAY AS THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 17362378 ↗
• MalfunctionJun 14, 2023Deflation 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 4.5X20 MM NC TREK BALLOON DILATATION CATHETER WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. THE CONTRAST MIX WAS 50ML CONTRAST AND 20ML SALINE. THE BALLOON WAS ADVANCED AND INFLATED ONCE AT A PRESSURE OF 14 ATMOSPHERES (ATMS). NEGATIVE WAS HELD FOR 5 SECONDS TO DEFLATE THE BALLOON. HOWEVER, THE BALLOON HAD POOR DEFLATION AND THE DEVICE WAS STUCK IN THE PATIENT. THE BALLOON PARTIALLY DEFLATED BUT WAS ULTIMATELY REMOVED FULLY DEFLATED WITH THE GUIDE CATHETER AND GUIDE WIRE AS A SINGLE UNIT. 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 17128295 ↗
• MalfunctionMay 31, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH HEAVY THROMBUS RELATED TO THE ST ELEVATION MYOCARDIAL INFARCTION (STEMI) AND THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITHOUT CALCIFICATION OR TORTUOSITY. THE 4.5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED OVER THE GUIDE WIRE. THE BDC WAS INFLATED BETWEEN NOMINAL TO RATED BURST PRESSURE (RBP). THERE WAS NO DIFFICULTY NOTED DURING INFLATION OR DEFLATION, AND THE BALLOON WAS FULLY DEFLATED. HOWEVER, WHEN THE BDC WAS REMOVED, IT WAS NOTED TO BE STUCK ON THE GUIDE WIRE AND BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE OUTER MEMBER WAS SEPARATED. THE ACCOUNT CONFIRMED THE SEPARATION WHICH REPORTEDLY OCCURRED WHEN THE BDC WAS ATTEMPTED TO BE REMOVED FROM THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035061 ↗
• MalfunctionMay 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 4.5 X 20 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND WAS USED IN A KISSING BALLOON TECHNIQUE. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE BALLOON WAS INFLATED TWICE, 7 SECONDS AT 12 ATMOSPHERES (ATMS) AND 14 SECONDS AT 14 ATMS, AND RUPTURED. ANOTHER BALLOON 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 16844045 ↗
• InjuryApr 28, 2023Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; 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. THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. DURING REMOVAL, RESISTANCE WAS NOTED AND FORCE WAS APPLIED. THE TIP AND THE 8-12 INCHES OF THE DISTAL END OF THE DELIVERY CATHETER BROKE OFF. IT WAS NOTED THAT THE BALLOON DID NOT COMPLETELY DEFLATE; WHICH WAS NOT INITIALLY REALIZE WHEN ATTEMPTING TO REMOVE THE BDC. AN ADDITIONAL GUIDEWIRE WAS ADVANCED BEYOND THE BDC IN AN ATTEMPT TO REMOVE THE DEVICE, BUT WAS UNSUCCESSFUL. THE BDC INCLUDING THE SEPARATED PORTION WAS ABLE TO BE REMOVED BY PULLING THE DEVICE BY PULLING IT OUT WITH THE GUIDE CATHETER AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834009 ↗
• InjuryMar 29, 2023Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Deflate; Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THE CONTRAST RATIO WAS 2:1 CONTRAST TO SALINE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640026 ↗
• MalfunctionMar 7, 2023Difficult to Remove; Failure to Deflate

  A NON-COMPLIANT BALLOON WAS USED TO POST DILATE THE RCA CORONARY/ STENT. THE BALLOON WAS INFLATED TO 14 ATM. FOR 24 SEC. AT CONCLUSION UNABLE TO DEFLATE THE BALLOON. NUMEROUS ATTEMPTS WERE MADE TO DEFLATE THE BALLOON. THE BALLOON WAS ABLE TO BE REMOVED FROM THE RCA TO THE AORTA. THE BALLOON WAS SUCCESSFULLY RUPTURED WITH OVER-INFLATION OF THE BALLOON. THE BALLOON WAS SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494924 ↗
• InjuryJan 16, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE BALLOON SEPARATED WHEN REMOVING THE DEVICE AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. FORCE WAS APPLIED. A SNARE WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE STENT WAS POST-DILATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16174052 ↗
• MalfunctionDec 13, 2022Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE THE 4.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 14 ATMOSPHERES; HOWEVER, DID NOT DEFLATE. IT WAS NOTED THE BALLOON BECAME STUCK IN THE RIGHT RADIAL ARTERY AS IT WAS REMOVED INFLATED. THE UNSPECIFIED GUIDE CATHETER AND GUIDE WIRE HAD TO BE REMOVED FIRST, THEN THE BDC WAS REMOVED WITH DIFFICULTY. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970574 ↗
• InjuryNov 28, 2022Difficult to Remove; Material Separation; Failure to Deflate; Difficult to Remove; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THE 4.5 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE AT A PRESSURE OF 16 ATMOSPHERES (ATMS) FOR 10 SECONDS EACH TIME BUT GOT STUCK IN THE VESSEL STILL INFLATED SINCE THE BALLOON NEVER DEFLATED AND WITH THE PREVIOUSLY IMPLANTED STENT. NEGATIVE WAS HELD BUT UNSURE OF HOW MANY SECONDS. AFTER REMOVING THE DEVICE WHICH WAS BELIEVED TO HAVE BEEN DEFLATED, IT WAS NOTED ON ANGIOGRAPHY THAT THE BALLOON MARKERS WERE STILL IN THE PATIENT AND CAUGHT ON THE STENT STRUT DURING POST-DILATATION. AN ATTEMPT TO REMOVE THE BALLOON USING A SNARE DEVICE WAS MADE BUT IT WAS STUCK IN THE VESSEL AND IT IS UNKNOWN IF AT THIS TIME THE BALLOON WAS STILL INFLATED. THE BALLOON WAS NEVER ABLE TO BE RETRIEVED. ONLY THE HUB AND SHAFT WERE REMOVED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND THE CONTRAST MIX WAS 50:50. THE PATIENT DIED ON (B)(6) 2022 AND THE PHYSICIAN DOES NOT BELIEVE THE NC TREK BALLOON CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. PATIENT PRESENTED WITH MU

  Patient problems: Foreign Body In Patient

  MAUDE report 15873490 ↗
• InjuryOct 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID RIGHT CORONARY ARTERY. FOR POST-DILATATION, A TREK BALLOON WAS INSERTED AND ADVANCED TO THE LESION. UNSPECIFIED NUMBER OF INFLATIONS WERE PERFORMED. DURING REMOVAL, SOME RESISTANCE WITH AN UNSPECIFIED SOURCE WAS MET AND THE SHAFT SEPARATED, REMAINING IN THE ANATOMY. ANOTHER NC TREK BALLOON WAS ADVANCED IN AN ATTEMPT TO RETRIEVE THE SEPARATED SHAFT OF THE FIRST BALLOON. HOWEVER, DURING ATTEMPTED REMOVAL, THE NC TREK SHAFT ALSO SEPARATED, ALTHOUGH NO RESISTANCE WAS MET. A 3RD UNSPECIFIED BALLOON WAS USED AND ADVANCED PAST THE TWO SEPARATED PORTIONS, INFLATED AND PULLED THE SEPARATED SHAFTS OUT OF THE PATIENT ANATOMY. NOTHING REMAINS IN THE PATIENT. THE PROCEDURE CONCLUDED AT THIS POINT. 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 15591209 ↗
• MalfunctionJun 9, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY. THE 4.5X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO DILATE THE LESION AND WAS INFLATED THREE TIMES TO 12 ATMOSPHERES (ATM). UPON DEFLATION, THERE WAS DIFFICULTY RETRACTING THE BALLOON INTO THE GUIDE CATHETER. THE BALLOON WAS DEFLATING SLOWLY. NEGATIVE WAS HELD FOR ABOUT 10 SECONDS. THE BALLOON WAS REMOVED SUCCESSFULLY WITHOUT LOSING WIRE POSITION AND THE PROCEDURE WAS COMPLETE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. UPON INSPECTION OUTSIDE THE ANATOMY THE PHYSICIAN STATED THE BALLOON WAS NOT FULLY DEFLATED; HOWEVER, THE BALLOON WAS INFLATED AND DEFLATED SEVERAL TIMES WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644089 ↗
• MalfunctionAug 25, 2021Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THIS WAS A CORONARY INTERVENTION PROCEDURE IN THE RIGHT CORONARY ARTERY. A NON-ABBOTT 4.0X30 MM STENT WAS IMPLANTED. THE 4.5X20 MM NC TREK WAS INSERTED TO POST-DILATE THE STENT. THE NC TREK WAS INFLATED FIVE TIMES; FIRST IN THE DISTAL STENT FOR 14 SECONDS AT 12 ATMOSPHERES (ATMS), THEN IN THE MORE PROXIMAL SEGMENT FOR 31 SECONDS AT 18 ATMS, AGAIN MORE PROXIMAL FOR 18 SECONDS AT 16 ATMS, THEN FOR 25 SECONDS AT 18 ATMS. THE FINAL INFLATION WAS AT THE OSTIUM RIGHT INSIDE THE STENT FOR 21 SECONDS AT 20 ATMS. THE NC TREK WAS REPORTED TO BE FULLY DEFLATED BEFORE IT WAS PULLED INTO THE GUIDE CATHETER FOR REMOVAL, BUT THE NC TREK BECAME STUCK IN THE GUIDE CATHETER. THE GUIDE CATHETER AND NC TREK WERE REMOVED TOGETHER ALONG WITH THE SHEATH. OUTSIDE THE BODY, THE NC TREK WAS FOUND TO BE SCRUNCHED UP FROM THE ATTEMPTS TO REMOVE IT FROM THE GUIDE CATHETER. THE NC TREK WAS ALSO DIFFICULT TO REMOVE FROM THE SHEATH AND THE NC TREK SEPARATED IN TWO PIECES. VESSEL ACCESS WAS LOST, SO A NEW SHEATH AND NEW GUIDE CATHETER WERE INSERTED. THE PROCEDURE WAS COMPLETED WITH GOOD FINAL RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367869 ↗
• MalfunctionAug 25, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 4.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND USED WITHOUT ISSUE. HOWEVER, THE BDC FELT RESISTANCE DURING REMOVAL WITH AN UNSPECIFIED GUIDING CATHETER BUT WAS REMOVED SUCCESSFULLY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12366766 ↗
• MalfunctionJun 9, 2021Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. A 4.0X38MM XIENCE SIERRA STENT AND A 4.0X18MM XIENCE SIERRA STENT WERE DEPLOYED SUCCESSFULLY WITHOUT ISSUES. ROUTINE POST-DILATATION WAS BEING PERFORMED WITH A 4.50X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC); HOWEVER, THE BALLOON RUPTURED AT 15 ATMOSPHERES. THE BDC WAS BEING REMOVED BUT RESISTANCE WITH THE ANATOMY WAS FELT. FORCE WAS APPLIED TO REMOVE THE BDC AND IT WAS NOTED THAT THE DISTAL SHAFT SEPARATED. AT THIS TIME THE BDC WAS REMOVED AS A UNIT WITH THE GUIDE WIRE AND GUIDE CATHETER AND THE SEPARATED DISTAL SHAFT ALSO CAME OUT. IMAGING OF THE DEPLOYED STENTS WAS DONE AND EVERYTHING LOOKED GOOD. 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 11970433 ↗
• InjuryMay 26, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  THIS IS BEING FILED TO REPORT THAT AFTER USE WITH THE NC TREK BALLOON CATHETER, THE DISTAL PORTION OF THE CATHETER SEPARATED IN THE ANATOMY, DURING REMOVAL REQUIRING MEDICAL INTERVENTION. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN OBTUSE MARGINAL CORONARY ARTERY. THE 4.5 X 20 MM NC TREK BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION BUT THERE WAS RESISTANCE DUE TO THE HEAVY CALCIFICATION. WHEN THE NC TREK BALLOON CATHETER WAS BEING REMOVED THERE WAS RESISTANCE AND THE DISTAL PORTION OF THE CATHETER SEPARATED IN THE ANATOMY. THE SEPARATED DISTAL PORTION REMAINED ON THE GUIDE WIRE. A SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE BALLOON CATHETER. A NEW NC TREK BALLOON CATHETER WAS ADVANCED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 11886647 ↗
• MalfunctionMay 12, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  SUBSEQUENT TO THE INITIALLY FILED REPORTS, THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAS HISTORY OF AND PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THE PROCEDURE WAS TO TREAT THE PROXIMAL RCA THAT WAS 100% OCCLUDED WITH CLOT. AFTER EACH INFLATION, 10 SECONDS WERE WAITED BEFORE ATTEMPTING DEFLATION. THE BALLOON DEFLATION ISSUE WAS NOT NOTICED UNTIL THE LAST INFLATION AND DEFLATION WAS ATTEMPTED FOR OVER 30 SECONDS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813397 ↗
• MalfunctionSep 3, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE GUIDE WIRE THAT BECAME CAUGHT IN THE 4.5X20MM NC TREK RX BALLOON DILATATION CATHETER WAS AN ABBOTT VASCULAR HT ADVANCE LITE, NOT A NON-ABBOTT GUIDE WIRE AS INITIALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10489690 ↗
• MalfunctionSep 1, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL REPORT, IT WAS NOTED THAT THE CONTRAST TO SALINE MIX WAS 1:2 AND SHOULD HAVE BEEN 1:1. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477551 ↗