NC TREK 1012453-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 08717648152078), received between Dec 7, 2015 and Feb 17, 2026 — classified as 1 death, 9 injuries, 73 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. 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-1130-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 88% STENOSIS. THE 4.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WITH THE ANATOMY WAS NOTED. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE AND A RUPTURE WAS NOTED DUE TO THE ANATOMY. ANOTHER NC TREK 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 24369252 ↗
• MalfunctionJul 8, 2025Break; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Break; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  IT WAS REPORTED THAT WHEN REMOVING THE PROTECTIVE SHEATH OF THE 4.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC), THE SHEATH WAS NOTED TO BE BROKEN. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A NEW, SAME SIZE DEVICE 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 22438266 ↗
• MalfunctionApr 15, 2025Deflation 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 PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, RIGHT CORONARY ARTERY THAT IS 90% STENOSED. AFTER A SUCCESSFUL IMPLANTATION OF AN UNSPECIFIED STENT, A 4.00 X 15 MM NC TREK BALLOON DILATATION CATHETER WAS USED FOR POST DILATION AT 20 ATMOSPHERES FOR ONE INFLATION. THE NC TREK BALLOON DID NOT DEFLATE ON THE FIRST ATTEMPT AND ONLY PARTIALLY DEFLATED AFTER THE SECOND ATTEMPT. DURING WITHDRAWAL OF THE PARTIALLY DEFLATED NC TREK BALLOON, RESISTANCE WAS MET DUE TO A PREVIOUSLY IMPLANTED STENT AND MORE FORCE THAN USUAL WAS APPLIED WHEN THE BALLOON WAS OBSERVED TO SEPARATE FROM THE SHAFT. THE NC TREK BALLOON, ITS DELIVERY SYSTEM, GUIDE WIRE, AND GUIDING CATHETER WERE REMOVED AS ONE UNIT. 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 21845059 ↗
• DeathMar 12, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE 4.0X15 MM NC TREK WAS USED FOR POST-DILATATION AFTER STENT IMPLANTATION. THE BALLOON WAS INFLATED TWICE TO 10-12 ATMOSPHERES BUT WOULD NOT DEFLATE. NEGATIVE PRESSURE WAS HELD FOR 2 MINUTES BUT THE BALLOON COMPLETELY FAILED TO DEFLATE. SEVERAL GUIDE WIRES AND A MICROCATHETER WERE ADVANCED TO ATTEMPT TO REMOVE THE DEVICE AS WELL AS AN ATTEMPT TO ADVANCE A 1X10 MM BALLOON. EVENTUALLY THE BALLOON WAS REMOVED STILL INFLATED TOGETHER WITH THE GUIDING CATHETER AND FORCE WAS APPLIED BUT THE DISTAL END (TIP) OF THE DEVICE AND ITS SHEATH DETACHED AND REMAINED IN THE ANATOMY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR BYPASS SURGERY AND THE PATIENT ULTIMATELY EXPIRED ON 02/18/2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21586646 ↗
• InjuryFeb 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 4X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE; HOWEVER, DURING REMOVAL OF THE BALLOON CATHETER, THE BALLOON SEPARATED. THEREFORE, AN UNSPECIFIED BALLOON WAS USED AS AN ANCHOR AND REMOVED THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349829 ↗
• MalfunctionJun 19, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN CORONARY ARTERY WITH 90% STENOSIS. DURING THE PROCEDURE, THE 4.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) INFLATED TWICE TO 8 ATMOSPHERES WITHOUT ISSUE; HOWEVER, THE BALLOON FAILED TO DEFLATE. NEGATIVE PRESSURE WAS HELD FOR 5 SECONDS. THE BALLOON WAS REMOVED WITH THE GUIDING CATHETER DUE TO RESISTANCE BETWEEN THE DEVICES AS THE BALLOON COMPLETELY FAILED TO DEFLATE. THE BALLOON WAS REPORTEDLY NOT PREPPED (AIR ASPIRATION) OUTSIDE OF THE ANATOMY PRIOR TO USE. A NEW GUIDING CATHETER AND BALLOON WERE 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 19568848 ↗
• MalfunctionJun 12, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT MAIN. THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TWICE TO 14 ATMOSPHERES. DURING DEFLATION CONTRAST WAS NOTED STILL IN THE BALLOON. DEFLATION WAS ATTEMPTED AGAIN AND THE BDC WAS REMOVED WITH RESISTANCE NOTED. IT WAS NOTED THE BALLOON WAS NOT COMPLETELY DEFLATED. AFTER STENTING POST DILATATION WAS PERFORMED WITH THE 4.0X12MM NC TREK HOWEVER WHEN DEFLATING THE BALLOON, CONTRAST WAS SEEN INSIDE BALLOON. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON AND RESISTANCE WAS MET DURING RETRACTION. THE BDC AND GUIDING CATHETER WERE REMOVED TOGETHER AS A UNIT. 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 19518808 ↗
• InjuryMar 14, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL COMMON TRUNK/LEFT ANTERIOR DESCENDING (LAD) WITH 99% STENOSIS (SPONTANEOUS DISSECTION IS THE PROBABLE CAUSE). THE NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED 3 TIMES. NEGATIVE WAS HELD 5-10 SECONDS FOR EACH INFLATION. THE BALLOON WAS FULLY DEFLATED; HOWEVER, THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND WAS ULTIMATELY WITHDRAWN AS A SINGLE UNIT. HOWEVER, SEPARATION OF THE BALLOON OCCURRED AND PARTS OF THE BALLOON WERE IN THE COMMON TRUNK/LAD WHICH LED TO THROMBOSIS WHICH WAS CONFIRMED BY ANGIOGRAPHY. THROMBOSIS WAS TREATED WITH MEDICATION. THE PATIENT WAS SENT TO CARDIAC SURGERY TO ASSESS THE PATIENT'S CONDITION AND TO INTERVENE IF NEEDED. THE PATIENT UNDERWENT A DOUBLE AORTOCORONARY BYPASS AND THE MATERIAL REMAINING IN THE CORONARY ARTERY WAS REMOVED VIA A TRANSAORTIC APPROACH. NOTHING REMAINS IN THE ANATOMY. PATIENT WAS HEMODYNAMICALLY STABLE AND IS IN CARDIOLOGIC REHABILITATION. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18905842 ↗
• MalfunctionMar 12, 2024Difficult to Remove; Material Rupture; Failure to Deflate; Difficult to Remove; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OSTIAL LEFT MAIN CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED AND AN UNSPECIFIED 4.0X18 MM DRUG ELUTING STENT WAS IMPLANTED. THE 4X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 14 ATMOSPHERES (ATM) THREE TIMES FOR POST-DILATATION AND RUPTURED. THERE WAS SIGNIFICANT RESISTANCE WITH THE ANATOMY WHEN PULLING OUT THE BDC AS IT WAS NOT FULLY DEFLATED UPON REMOVAL. AFTER SEVERAL ATTEMPTS THE ENTIRE SYSTEM ALONG WITH GUIDEWIRE AND GUIDING CATHETER WERE REMOVED TOGETHER AS A UNIT. 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 18890533 ↗
• MalfunctionFeb 26, 2024Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS IMPLANTED. THE NC TREK RX 4.00 X 15MM BALLOON DILATATION CATHETER (BDC) WAS SELECTED TO BE USED. IT WAS NOTED THAT THERE WAS DIFFICULTY REMOVING THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED FOR POST-DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE. SEVERAL ATTEMPTS WERE MADE TO INFLATE THE BALLOON AND THE INFLATION DEVICE WAS REPLACED; HOWEVER, THE BALLOON STILL DID NOT INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANTLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784517 ↗
• MalfunctionFeb 22, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. AFTER IMPLANTATION OF A 4X28MM NON-ABBOTT STENT, THE 4X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FOR POST-DEPLOYMENT. HOWEVER, THE BALLOON RUPTURED AFTER 5 SECONDS AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A PINHOLE RUPTURE WAS CONFIRMED. NO ADDITIONAL TREATMENT WAS PERFORMED TO COMPLETE 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 18763603 ↗
• MalfunctionFeb 22, 2024Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE PROTECTIVE SHEATH OF THE 4X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED WITH DIFFICULTY. AFTER PRE-DILATATION AND IMPLANTATION OF A NON-ABBOTT STENT, THE NC TREK BDC WAS ADVANCED FOR POST-DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE. SEVERAL ATTEMPTS WERE MADE TO INFLATE THE BALLOON AND THE INFLATION DEVICE WAS REPLACED; HOWEVER, THE BALLOON STILL DID NOT INFLATE. THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANTLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760255 ↗
• MalfunctionNov 30, 2023Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A STENT WAS IMPLANTED IN THE RCA AND THE 4.0X15 MM NC TREK WAS USED FOR POST DILATATION; HOWEVER, THERE WAS RESISTANCE WHEN REMOVING THE STYLET/PROTECTIVE SHEATH. THE BALLOON WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND THE CONTRAST MIX WAS NORMAL SALINE. THE NC TREK BALLOON WAS INFLATED ONCE DURING THE PROCEDURE, TO 12 ATMOSPHERES (ATM) FOR 9 SECONDS. NEGATIVE PRESSURE WAS HELD FOR 2 SECONDS. THE TIP OF THE BALLOON WAS WRINKLED AND THE BALLOON WAS STUCK IN THE STENT. AFTER REPEATED ATTEMPTS, THE BALLOON WAS ABLE TO BE REMOVED INDEPENDENTLY, BUT THERE WAS REWRAP ISSUES AND THE BALLOON WAS CORKSCREWED. AFTER THE PROCEDURE THE BALLOON WAS INFLATED AGAIN TO 12 ATM FOR 4 SECONDS TO SEE IF IT WOULD WORK. 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 18240151 ↗
• MalfunctionNov 29, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X15MM NC TREK BALLOON DILATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR POST-DILATATION OF A 4.0X15MM NON-ABBOTT STENT; HOWEVER, AFTER SEVERAL ATTEMPTS THE BALLOON FAILED TO INFLATE. AN ATTEMPT WAS MADE WITH ANOTHER INDEFLATOR, BUT THE BALLOON STILL DID NOT INFLATE. IT WAS CONFIRMED THAT THE NC TREK WAS LOSING PRESSURE DURING THE ATTEMPTS TO INFLATE THE BALLOON. THE BDC WAS REMOVED FROM THE PATIENT AND A NEW SAME SIZE NC TREK WAS USED TO COMPLETE 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 18234653 ↗
• MalfunctionSep 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION OF AN UNSPECIFIED IMPLANTED STENT; HOWEVER, THE BDC DID NOT DEFLATE AFTER INFLATION. 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 17814155 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR POST DILATATION; HOWEVER, A RUPTURE OCCURRED ON THE FIRST INFLATION AT 8 ATMOSPHERES. ANOTHER NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORTS, THE DEVICE WAS RECEIVED AND THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT PARTS OF THE INNER/OUTER MEMBER WERE SEPARATED AND NOT RETURNED. ADDITIONALLY A PORTION OF THE PROXIMAL BALLOON MARKER WAS POSSIBLY MISSING A PORTION WHICH WAS NOT RETURNED. THEREFORE, THERE IS THE POTENTIAL THE MISSING PIECES NOT RETURNED REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436239 ↗
• MalfunctionJun 30, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED LESION IN THE CIRCUMFLEX OSTIUM AND LEFT CORONARY TRUNK. TWO 4.0X15MM NC TREK BALLOON DILATATION CATHETERS (BDC) WERE USED AND HAD THE SAME ISSUE. AFTER BEING FULLY DEFLATED, THE BDC¿S WERE TRAPPED INSIDE THE GUIDING CATHETER. ONE OF THE BDC¿S SEPARATED AT THE SHAFT AND WAS SIMPLY REMOVED WITH THE GUIDING CATHETER. THE SECOND BDC DETACHED FROM THE GUIDE CATHETER AND IT WAS ALMOST IMPOSSIBLE TO EXTRACT IT USING THE RADIAL INTRODUCER; HOWEVER, THE INTRODUCER WAS ALREADY IN THE PATIENT AND IT WAS ABLE TO REMOVE THE SEPARATED PORTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243493 ↗
• MalfunctionJun 30, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED LESION IN THE CIRCUMFLEX OSTIUM AND LEFT CORONARY TRUNK. TWO 4.0X15MM NC TREK BALLOON DILATATION CATHETERS (BDC) WERE USED AND HAD THE SAME ISSUE. AFTER BEING FULLY DEFLATED, THE BDC¿S WERE TRAPPED INSIDE THE GUIDING CATHETER. ONE OF THE BDC¿S SEPARATED AT THE SHAFT AND WAS SIMPLY REMOVED WITH THE GUIDING CATHETER. THE SECOND BDC DETACHED FROM THE GUIDE CATHETER AND IT WAS ALMOST IMPOSSIBLE TO EXTRACT IT USING THE RADIAL INTRODUCER; HOWEVER, THE INTRODUCER WAS ALREADY IN THE PATIENT AND IT WAS ABLE TO REMOVE THE SEPARATED PORTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243490 ↗
• MalfunctionJun 5, 2023Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn; Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS ADVANCED SUCCESSFULLY AND PRE-DILATATION WAS PERFORMED USING MULTIPLE NON-ABBOTT BALLOONS. THE MID LAD WAS FURTHER TREATED USING A 3.5X38MM XIENCE SIERRA STENT AND WAS POST DILATATED WITH A 3.5X12MM NC TREK BALLOON PER STANDARD PROCEDURE. THE PROXIMAL LAD WAS TREATED SUCCESSFULLY USING A 4.0X28MM XIENCE SIERRA STENT, HOWEVER, POST-DILATATION PER STANDARD PROCEDURE WAS ATTEMPTED BUT THE 4.0X15MM NC TREK COULD NOT BE ADVANCED POSSIBLY DUE TO THE GUIDE WIRE. ANOTHER 4.0X15MM NON-ABBOTT NON-COMPLIANT (NC) BALLOON AND ANOTHER 5.0X12MM NC TREK BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A LONGITUDINAL TEAR IN THE INNER MEMBER 4.9CM PROXIMAL TO THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 0.5MM. THERE WAS A LONGITUDINAL TEAR IN THE OUTER MEMBER 5CM PROXIMAL TO THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 0.5MM. THE ACCOUNT WAS NOT AWARE OF THE TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058776 ↗
• MalfunctionMay 30, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY THAT IS 85% STENOSED. THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) PROXIMAL SHAFT SEPARATED DURING ADVANCEMENT OUTSIDE THE PATIENT. RESISTANCE WAS FELT WITH THE UNSPECIFIED GUIDE WIRE AND GUIDE CATHETER DURING ADVANCEMENT. THEREFORE, THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. ANOTHER SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. 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 17023856 ↗
• MalfunctionMay 9, 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 PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. TWO STENTS WERE IMPLANTED AND THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE FOR POST DILATATION. HOWEVER, THERE WAS RESISTANCE WITH THE IMPLANTED STENT UPON REMOVAL AND FORCE WAS APPLIED. THE SHAFT SEPARATED AT THE HUB AND THE WHOLE SYSTEM WAS SIMPLY WITHDRAWN. NOTHING WAS LEFT IN THE PATIENT. 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 16895950 ↗
• MalfunctionMay 9, 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 PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITHOUT CALCIFICATION AND TORTUOSITY. THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATATION AND USED WITHOUT ISSUES. THE SAME BALLOON WAS USED A SECOND TIME AND WAS ADVANCED WITHOUT RESISTANCE FOR POST DILATATION. HOWEVER, THE BALLOON GOT STUCK UPON REMOVAL AND FORCE WAS APPLIED. THE SHAFT SEPARATED AND THE WHOLE SYSTEM WAS SIMPLY WITHDRAWN. NOTHING WAS LEFT IN THE PATIENT. 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 16895935 ↗
• MalfunctionApr 27, 2023Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. AFTER POST-DILATATION WITH A 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS NOTED DURING REMOVAL WITH ANATOMY, GUIDE WIRE AND GUIDE CATHETER. IT WAS NOTE THE BDC WAS FULLY DEFLATED DURING REMOVAL. ONCE REMOVED THE BDC LOOKED BUNCHED UP. A NEW NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 16824757 ↗
• MalfunctionMar 6, 2023Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX (CX) INTO LEFT MAIL (LM) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE NC TREK BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 10 ATMOSPHERES (ATM) AND DEFLATED WITHOUT ISSUE, AND REMOVED FROM THE PATIENT. AFTER STENT IMPLANTATION, THE BALLOON WAS RE-ADVANCED TO THE STENTED LESION. THE BALLOON WAS INFLATED 4 MORE TIMES TO 10ATM, BUT AFTER THE FOURTH INFLATION, THE BALLOON FAILED TO DEFLATE. MULTIPLE ATTEMPTS TO DEFLATED THE BALLOON WITH AN INDEFLATOR WERE UNSUCCESSFUL. ADDITIONALLY A SYRINGE WAS USED TO DEFLATE THE BALLOON.THE BALLOON WAS PULLED INFLATED INTO THE AORTA AND WAS EITHER PARTIALLY OR COMPLETED DEFLATED IN THE AORTA, THEN WAS ABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIOINAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492108 ↗
• InjuryMar 6, 2023Deflation Problem; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE BDC HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED TWICE AT 20 ATMOSPHERES (ATMS). DURING DEFLATION, THE BALLOON WAS SLOW TO DEFLATE. THE BALLOON HAD TO BE RE-INFLATED THEN DEFLATED AND WAS ULTIMATELY DEFLATED. THE CONTRAST MIX WAS PER INSTRUCTION FOR USE (IFU). THERE WAS NO RESISTANCE DURING REMOVAL. HOWEVER, THE CATHETER BROKE UPON REMOVAL LEAVING THE PORTION OF THE DEVICE IN THE LAD. ANOTHER GUIDEWIRE AND BALLOON WERE PUT IN ALONGSIDE THE DEVICE AND THEY WERE ABLE TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO ADVERSE 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 16485383 ↗