NC TREK 1012451-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08717648151996), received between Sep 15, 2016 and Feb 20, 2026 — classified as 1 death, 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (12 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Rupture

  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 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A BALLOON LEAKAGE WAS NOTED DURING INFLATION (RUPTURE). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER NC TREK BDC WAS USED TO CONTINUE 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 24403036 ↗
• MalfunctionFeb 3, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE 3.50X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOTED TO HAVE THE SHAFT SEPARATED DURING REMOVAL IN THE UNSPECIFIED GUIDE CATHETER AS RESISTANCE WAS MET. THE SEPARATED PORTION REMAINED IN THE UNSPECIFIED GUIDING CATHETER AND WAS SIMPLY REMOVED WHEN THE GUIDING CATHETER WAS WITHDRAWN. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 16293863 ↗
• InjuryNov 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) TO THE POSTERIOR DESCENDING ARTERY (PDA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.50X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED WITHOUT ISSUE AND THEN ADVANCED TO THE TARGET LESION. WHEN ATTEMPTING TO INFLATE THE BALLOON THE NEEDLE ON THE INDEFLATOR INDICATED THAT THE BALLOON WOULD NOT MAINTAIN PRESSURE. AIR BUBBLES WERE NOTED IN THE ARTERY AND THE PATIENT EXPERIENCE CHEST PAIN DUE TO THE AIR EMBOLUS. THEREFORE THE PHYSICIAN ADMINISTERED MULTIPLE ROUNDS OF INTRACORONARY ADENOSINE AND AN INTEGRILIN BOLUS. THE AIR EMBOLI WORKED ITS WAY OUT THROUGH CAPILLARIES AND BLOOD FLOW WAS RE-ESTABLISHED. NO FURTHER TREATMENT WAS PROVIDED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Angina

  MAUDE report 15875055 ↗
• MalfunctionSep 30, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. AFTER IMPLANTATION OF AN UNSPECIFIED STENT AND RE-CROSSING OF THE BALANCE MIDDLEWEIGHT UNIVERSAL LL (BMW LL) GUIDE WIRE (GW) TO THE CIRCUMFLEX ARTERY, AND ALTHOUGH REACHING THE TARGET LESION, RESISTANCE WITH THE NC TREK BALLOON OVER THE GW WAS MET AND THE BALLOON CATHETER FRACTURED WITHIN THE GUIDE CATHETER (BUT REMAINED IN ONE PIECE). THE NC TREK AND BMW LL GW WERE REMOVED AND REPLACED. A SECOND BMW LL GW WAS ATTEMPTED AND ALSO GENERATED THE SAME ISSUE IN RESISTANCE ADVANCING WITH THE BALLOON CATHETER. A NEW GUIDE WIRE AND BALLOON WERE 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 15521902 ↗
• MalfunctionAug 13, 2022Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD SOME RESISTANCE WHEN REMOVING THE PROTECTIVE SHEATH. RESISTANCE WAS MET WITH ANATOMY DURING ADVANCEMENT AND ONCE AT THE LESION THE BDC RUPTURED DURING THE FIRST INFLATION AT 20 ATMOSPHERES. DURING REMOVAL RESISTANCE WAS FELT WITH ANATOMY. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WASP PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222646 ↗
• MalfunctionFeb 11, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X20 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR POST-DILATATION; HOWEVER, THE BALLOON ONLY PARTIALLY INFLATED AT 11 ATMOSPHERES AND THREE INFLATIONS. ANOTHER NC TREK WAS ABLE TO BE INFLATED TO 20 ATMOSPHERES WITHOUT ISSUE TO POST DILATE THE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED A PINHOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515917 ↗
• MalfunctionNov 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 2 ATMOSPHERES. THE BDC WAS REMOVED AND ANOTHER 3.5X20MM NC TREK 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12770684 ↗
• MalfunctionOct 6, 2021Deflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO POST-DILATE A PREVIOUSLY IMPLANTED STENT IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE TREK BALLOON DILATATION CATHETER HAD A CONTRAST MIX OF 1/3 CONTRAST AND 2/3 SALINE AND WAS INFLATED ONCE TO NOMINAL PRESSURE AND UPON THE SECOND INFLATION IT WAS FOUND THAT THE BALLOON WASN'T INFLATING AND A RUPTURE WAS SUSPECTED. THE PRESSURE WAS NOT KNOWN. THERE WAS SOME DIFFICULTY DEFLATING THE BALLOON. NEGATIVE PRESSURE WAS APPLIED FOR ABOUT 15 SECONDS AND WHEN ATTEMPTING TO REMOVE THE BALLOON THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND SOME FORCE WAS USED, BUT ALL DEVICES WERE REMOVED AS A UNIT AT THAT POINT. WHEN THE BALLOON WAS REMOVED IT WAS FOUND THAT THE SHAFT HAD SEPARATED BUT THE SEPARATED PORTION WAS IN THE GUIDE CATHETER WITH THE REST OF THE DEVICE SO THERE WAS NO INTERVENTION. ADDITIONALLY, IT WAS NOTED THAT THE BALLOON WAS NOT FULLY DEFLATED. ANOTHER, SAME SIZE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583978 ↗
• InjuryJun 14, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. ASPIRATION THROMBECTOMY WAS PERFORMED AND THREE OVERLAPPING STENTS WERE IMPLANTED USING NON-ABBOTT STENTS. POST DILATATION WAS PERFORMED WITH THE 3.5X20 NC TREK INFLATED TO 22 ATMOSPHERES. SUBSEQUENT ANGIOGRAPHY REVEALED A MODERATE-SIZED CONTAINED VESSEL INJURY. PROLONGED BALLOON INFLATION WAS PERFORMED FOR APPROXIMATELY TWENTY MINUTES, BUT THERE CONTINUED TO BE COMMUNICATION TO THE CONTAINED SPACE. THERE WAS NO SIGNIFICANT PERICARDIAL EFFUSION. THE 2.8X16 MM GRAFTMASTER STENT WAS IMPLANTED AT 22 ATMOSPHERES TO TREAT THE PERFORATION AND IT SUCCESSFULLY SEALED IT. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 11995891 ↗
• MalfunctionMar 3, 2021Inflation Problem; Stretched; Inflation Problem; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE LEFT CIRCUMFLEX ARTERY. A 3.5X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) FAILED TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.5X20MM NC TREK RX BDC. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE OUTER MEMBER (SHAFT) WAS STRETCHED AT THE LOCATION OF THE MID LAP SEAL FOR A LENGTH OF APPROXIMATELY .25MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408193 ↗
• MalfunctionDec 21, 2020Inflation Problem; Stretched; Inflation Problem; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID RIGHT CORONARY ARTERY. A 3.5X20MM NC TREK BALLOON COMPLETELY FAILED TO INFLATE. IT WAS CONFIRMED THAT THERE WAS NO LEAK OR LOOSE CONNECTION. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE TO THE LESION. ANOTHER 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. DEVICE ANALYSIS REPORTED THE INNER MEMBER AND OUTER MEMBER (SHAFT) WERE STRETCHED 1MM PROXIMAL TO THE PROXIMAL SEAL FOR A LENGTH OF APPROXIMATELY 1.5MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049634 ↗
• MalfunctionDec 21, 2020Inflation Problem; Stretched; Inflation Problem; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED MID RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED WITH A 2X20MM MINI TREK BALLOON UNDER A PRESSURE OF 10 ATMOSPHERES (ATMS). THEN A 3.5X48MM NON-ABBOTT STENT WAS POSITIONED AND IMPLANTED AT THE LESION. POST-DILATATION WAS THEN DECIDED TO BE PERFORMED WITH A 3.5X20MM NC TREK BALLOON, BUT WHEN DILATED THE BALLOON COMPLETELY FAILED TO INFLATE ALTHOUGH THE INDEFLATOR SHOWED A PRESSURE OF 14 ATMS. THE BALLOON WAS SIMPLY REMOVED WITHOUT ISSUE. WHEN BEING ADVANCED THERE WAS NO RESISTANCE NOTED. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT VIA TROUBLESHOOTING, BUT IT STILL FAILED TO INFLATE ALTHOUGH BEING PRESSURIZED AT 20 ATMS. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THERE WAS NO LEAK OR LOOSE CONNECTION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. 12/9/20: DEVICE ANALYSIS NOTED THE INNER MEMBER AND OUTER MEMBER (SHAFT) WERE STRETCHED 1MM PROXIMAL TO THE PROXIMAL SEAL FOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11047208 ↗
• InjuryNov 20, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO STENTS WERE IMPLANTED AND A 3.50 X 20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION WHEN AN AIR EMBOLISM WAS NOTED. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. CARDIOPULMONARY RESUSCITATION (CPR) AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) WERE PERFORMED. THE PATIENT REGAINED CONSCIOUSNESS AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). AFTER THE PROCEDURE, THE BDC WAS INSPECTED AND THE SHAFT WAS NOTED TO BE FRACTURED (NOT SEPARATED) AND TORN. THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Angina; Cardiac Arrest

  MAUDE report 10876526 ↗
• DeathNov 10, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. A 3.5X20MM NC TREK RX ADVANCED AND DILATED THE MID LAD LESION WITHOUT A DEVICE ISSUE. DURING RETRACTION OF THE NC TREK INTO THE GUIDELINER, RESISTANCE WAS MET AND A PERFORATION OCCURRED. THE NC TREK WAS RETRACTED OUT OF THE ANATOMY WITHOUT ANY OTHER DEVICE ISSUE NOTED. BALLOON ANGIOPLASTY WAS PERFORMED AND A XIENCE STENT WAS SUCCESSFULLY IMPLANTED. FOLLOWING, A 3.5X19MM GRAFTMASTER STENT WAS SUCCESSFULLY IMPLANTED, SEALING THE PERFORATION. AFTER APPROXIMATELY 15 MINUTES POST-PROCEDURE, THE PATIENTS BECAME HYPOTENSIVE AND BRADYCARDIC. MEDICATIONS WERE PROVIDED AND A PERICARDIOCENTESIS WAS PERFORMED WITH NO SIGNIFICANT AMOUNT OF BLOOD OBSERVED. PER ECHOCARDIOGRAM, THE PERFORATION SITE HAD EXPANDED INTO THE COLLATERALS. THE GRAFTMASTER STENT REMAINED SEALING THE INTENDED IMPLANTATION SITE, WITHOUT A DEVICE MALFUNCTION. THE PERFORATION WAS LARGER THAN THE GRAFTMASTER STENT AND THERE WAS NO DEVICE MALFUNCTION. THE PATIENT WENT INTO CARDIAC SHOCK WITH PULSELESS ELECTRICAL ACTIVITY. MEDICATIONS WERE PROVIDED AND CARDIO-PULMONARY RESUSCIT

  Patient problems: Bradycardia; Cardiac Arrest; Cardiogenic Shock; Death; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 10818049 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY STENTING PROCEDURE, A 3.0 X 15 MM XIENCE SIERRA DRUG-ELUTING STENT WAS DEPLOYED ACROSS THE DISTAL STENOSIS AT 16 ATMOSPHERES. AT THAT TIME, THERE WAS A DISRUPTION OF THE PROXIMAL TO MID RIGHT CORONARY ARTERY STENOSIS AND THE DECISION WAS MADE TO COVER THIS AREA WITH A DRUG-ELUTING STENT. A 3.5 X 28 MM XIENCE SIERRA WAS THEN SUCCESSFULLY IMPLANTED AND POST-DILATED WITH A 3.5X20MM NC TREK. AFTER POST-DILATATION, A PERFORATION WAS NOTED. AT THAT TIME, A 3.5 X16 MM GRAFTMASTER COVERED STENT (9072241) WAS IMPLANTED ACROSS THE PERFORATION AT 20 ATMOSPHERES (ABOVE RATED BURSE PRESSURE), RESOLVING THE PERFORATION; HOWEVER, THE STENT WAS POST-DILATED WITH THE 3.5X20MM NC TREK AND THE PERFORATION WAS NOTED TO CONTINUE TO LEAK. TWO ADDITIONAL 3.5X19 GRAFTMASTER STENTS (9112841, 9032941) WERE IMPLANTED, ONE PROXIMAL AND ONE DISTAL TO THE IMPLANTED 3.5X16MM GRAFTMASTER STENT, BUT THE PERFORATION CONTINUED TO LEAK. AN ADDITIONAL XIENCE SIERRA 3.5 X 38 MM STENT WAS IMPLANTED BUT THE PERFORATION CONTINUED TO LEAK. A 2.8X19MM GRAFTMASTER STENT (8120641) WAS ADVANCED, BUT FAILED TO GET DISTAL TO THE LAST GRAFTMASTER STENT AND THE XIENCE SIERRA. ANO

  Patient problems: Perforation

  MAUDE report 10759282 ↗
• MalfunctionJan 17, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. WHILE ADVANCING THE NC TREK ONTO THE GUIDE CATHETER, RESISTANCE WAS MET AND THE PROXIMAL SHAFT SEPARATED IN TWO PIECES. THE DEVICE WAS SIMPLY WITHDRAWN AND ANOTHER SAME SIZE 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 9602029 ↗
• MalfunctionDec 27, 2019Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH HEAVY CALCIFICATION AND NO TORTUOSITY IN THE PROXIMAL MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ATHERECTOMY WAS PERFORMED AND THEN A 3.5 X 20 MM VOYAGER NC BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE BALLOON WAS INFLATED THREE TIMES TO 16 ATMOSPHERES. THE BALLOON DEFLATED NORMALLY BUT RE-WRAP OF THE BALLOON WAS NOT NORMAL. THE BALLOON DEFLATED LIKE A PANCAKE; THEREFORE, THERE WAS DIFFICULTY REMOVING THE BALLOON THROUGH THE GUIDING CATHETER. THE GUIDING CATHETER HAD TO BE REMOVED FIRST, THEN THE VOYAGER NC WAS REMOVED WITHOUT ISSUE. A STENT WAS IMPLANTED SUCCESSFULLY COMPLETING THE PROCEDURE. 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 9526048 ↗
• MalfunctionDec 5, 2019Material Separation; Material Separation

  A 3.5X20MM NC TREK BALLOON DILATATION CATHETER WAS RECEIVED IN THE ABBOTT VASCULAR RETURN GOODS LAB WITH A SEPARATED HUB, LOOSELY FOLDED BALLOON, AND CONTRAST IN THE BALLOON AND THROUGHOUT THE DEVICE. NO ADDITIONAL INFORMATION REGARDING THE DEVICE OR PROCEDURE COULD BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416844 ↗
• MalfunctionNov 13, 2019Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT THE PROTECTIVE SHEATH OF THE 3.5X20 MM NC TREK BALLOON DILATATION CATHETER (BDC)WAS DIFFICULT TO BE REMOVED. THE BDC WAS FLUSHED AND PREPPED PER USUAL BUT THE SHEATH WAS VERY TIGHT AND CAME OFF AFTER A FEW ATTEMPTS. AN ATTEMPT WAS MADE TO INSERT A GUIDE WIRE, BUT IT WAS UNSUCCESSFUL. THE DEVICE NEVER ENTERED THE PATIENT. A NEW, SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316515 ↗
• MalfunctionSep 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE LOADING THE NC TREK INTO THE GUIDE CATHETER, THE SHAFT SEPARATED IN TWO PIECES OUTSIDE THE PATIENT. THERE WAS NO REPORTED RESISTANCE REPORTED DURING ADVANCEMENT OR RETRACTION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9137706 ↗
• MalfunctionSep 5, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 20 MM NC TREK BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE AS CONTRAST LEAKAGE WAS NOTED. THEREFORE, ANOTHER 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 8966753 ↗
• MalfunctionAug 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS BEING USED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 8922356 ↗
• InjuryAug 6, 2019Entrapment of Device; Material Separation; Stretched; Entrapment of Device; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING REMOVAL OF A3.50X20MM NC TREK BALLOON DILATATION CATHETER AFTER INFLATION, RESISTANCE WAS MET WITH THE ANATOMY AND THE CATHETER SHAFT BECAME STRETCHED. A 1.5MM UNSPECIFIED BALLOON WAS USED TO INFLATE THE STUCK PORTION AND EVERYTHING WAS ABLE TO BE REMOVED SUCCESSFULLY WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019: THE PROXIMAL SHAFT BECAME SEPARATED DURING THE PROCEDURE DURING REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865780 ↗
• MalfunctionJan 15, 2019Inflation Problem; Material Separation; Inflation Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY, HEAVY CALCIFICATION AND 90% STENOSIS. A 3.5 X 20 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR PRE-DILATATION; HOWEVER, ON ATTEMPTING TO INFLATE THE BALLOON TO THE RATE OF BURST PRESSURE (RBP) THE BALLOON COMPLETELY FAILED TO INFLATE. A NON-ABBOTT 3.5 X 20 MM BALLOON CATHETER WAS USED TO SUCCESSFULLY PRE-DILATE THE LESION PRIOR TO THE DEPLOYMENT OF A 3.5 X 48 MM XIENCE XPEDITION STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS IDENTIFIED THAT THE HYPOTUBE WAS SEPARATED 0.5 MM DISTAL TO THE HUB. THE STRAIN RELIEF TUBING WAS KINKED AT THE SAME LOCATION AS THE SEPARATION BUT WAS STILL INTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251110 ↗
• MalfunctionSep 4, 2018Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 100% OCCLUDED, MILDLY CALCIFIED, NON-TORTUOUS LESION IN THE MID CIRCUMFLEX (CX) CORONARY ARTERY. AN UNSPECIFIED DRUG ELUTING STENT WAS IMPLANTED IN THE TARGET LESION. A 3.50X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED TO THE LESION TO PERFORM POST-DILATATION AND WAS INFLATED TWO TIMES AT 14 ATMOSPHERES FOR 40 SECONDS. FOLLOWING THE INFLATION, THE BDC WAS HELD NEGATIVE FOR APPROXIMATELY 5 SECONDS WHEN IT WAS NOTED THAT THE DISTAL TIP OF THE BALLOON WOULD NOT DEFLATE PROPERLY. THE BALLOON REMAINED PARTIALLY INFLATED AND WAS NOT ABLE TO BE PULLED INTO THE NON-ABBOTT GUIDING CATHETER, AND BOTH THE BDC AND GUIDING CATHETER WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. NO ADDITIONAL DEVICES WERE USED AND THE PROCEDURE CONCLUDED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842588 ↗