NC TREK 1012451-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 08717648151989), received between Aug 22, 2016 and Jun 1, 2026 — classified as 11 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (35 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION TO POST DILATE A STENT HOWEVER WHEN INFLATING TO 10 ATMOSPHERES, A LEAK WAS NOTED AT THE PROXIMAL PORTION OF THE BALLOON. THE BDC WAS REMOVED AND ANOTHER ONE WAS USED 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 25348764 ↗
• MalfunctionApr 22, 2026Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LATERAL ANTERIOR DESCENDING ARTERY LESION WITH 80% STENOSIS. THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, AFTER THE FIRST INFLATION AT 12 ATM, THE BALLOON WAS NOT ABLE TO BE FULLY DEFLATE. THE BALLOON GOT STUCK AT THE TIP OF THE GUIDING CATHETER AND WAS UNABLE TO BE REMOVED FROM THE BODY. DURING THE RETRACTION PROCESS, THE PROXIMAL SHAFT SEPARATED. EVENTUALLY, THE BALLOON WAS DEFLATED, AND ALL DEVICE SEGMENTS WERE WITHDRAWN INDEPENDENTLY. THE PROCEDURE WAS COMPLETED. 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 24956275 ↗
• MalfunctionFeb 11, 2026Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR DESCENDING LESION WITH 80% STENOSIS. THE 3.50X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, RESISTANCE WAS FELT DURING ADVANCEMENT AND THE PROXIMAL SHAFT SEPARATED. THE REMAINING PART WAS REMOVED MANUALLY WITHOUT ISSUE. AN ADDITIONAL NC TREK RX 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 24315268 ↗
• MalfunctionDec 16, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY TORTUOUS AND 99% STENOSED RIGHT CORONARY ARTERY. AN NC TREK RX 3.50X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND INFLATED TO 12-14ATM. HOWEVER, A PRESSURE LEAK WAS DETECTED, AND UPON INSPECTION, A BALLOON RUPTURE WAS OBSERVED. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH ANOTHER 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 23822717 ↗
• MalfunctionNov 7, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 85% STENOSIS. THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES; HOWEVER, A LEAK WAS SEEN FROM THE BALLOON [RUPTURE]. A NEW NC TREK 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 20632809 ↗
• MalfunctionSep 25, 2024Stretched; Deformation Due to Compressive Stress; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 85% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION OF AN IMPLANTED STENT; HOWEVER, THE STENT WAS NOT FULLY EXPANDED UPON INTRAVASCULAR ULTRASOUND CHECK. THE PHYSICIAN WANTED TO USE THE SAME NC TREK BALLOON TO EXPAND THE VESSEL AGAIN BUT FOUND THE SHAFT BENT AS THE DEVICE WAS BEING DELIVERED INTO THE GUIDING CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE BALLOON WAS TIGHTLY FOLDED. THE OUTER AND INNER MEMBER WERE STRETCHED DISTAL TO THE MID-LAP FOR A LENGTH OF 9 CENTIMETERS (CM). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304976 ↗
• MalfunctionJun 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED IN THE PROCEDURE AND THE BALLOON WAS INFLATED 3-4 TIMES TO 8-12 ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT HOLD PRESSURE AND WOULD ONLY PARTIALLY INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK WAS USED IN 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 19512178 ↗
• MalfunctionNov 27, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE WITH RESISTANCE TO THE TARGET LESION. THE BALLOON WAS INFLATED TWICE FOR 4 SECONDS; HOWEVER, A RUPTURE OCCURRED DURING THE SECOND INFLATION AT 9 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND RESISTANCE WAS ALSO NOTED WITH THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BDC WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210916 ↗
• InjurySep 27, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATATION WITH RESISTANCE NOTED WITH THE ANATOMY AND THE 7FR SHEATH. THE BALLOON WAS INFLATED TO 18 ATMOSPHERES. THE BALLOON WAS DEFLATED AND REMOVED FROM THE ANATOMY WITH RESISTANCE NOTED WITH THE ANATOMY AND THE 7FR SHEATH; HOWEVER, THE SHAFT SEPARATED WHEN FORCE WAS USED. A NON-ABBOTT BALLOON WAS USED TO RETRIEVE THE REMAINING PIECE INTO THE GUIDING CATHETER. A ROTABLATOR WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17829486 ↗
• MalfunctionSep 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X15MM NC TREK BALLOON RUPTURED AT RATED BURST PRESSURE AFTER 3-4 INFLATIONS. A 3.5X12MM 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 17804017 ↗
• MalfunctionSep 11, 2023Inflation Problem; Off-Label Use; Material Split, Cut or Torn; Inflation Problem; Off-Label Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT COMMON FEMORAL ARTERY. A 3.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO POST-DILATATE AN IMPLANTED STENT, HOWEVER, THE BALLOON ONLY INFLATED TO 8 ATMOSPHERES (ATM). THE BDC WAS PREPARED WITHOUT ISSUE AND THERE WERE NO NOTED LEAKS OR RUPTURES IN THE BALLOON. A 3.50X12MM NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE RETURNED DEVICE HAD A LONGITUDINAL LEAK BETWEEN THE MIDDLE OF THE INFLATION LUMEN AND GUIDE WIRE LUMEN AND EXHIBITED THINNED, STRETCHED, AND TORN MATERIAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725607 ↗
• MalfunctionAug 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 75% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE AND INFLATED ONE TIME TO 12 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND A NEW NC TREK WAS USED TO SUCCESSFULLY 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 17590047 ↗
• MalfunctionMay 4, 2023Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE 3.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION. AFTER THE FIRST INFLATION IT WAS NOTED THAT THAT THE BALLOON WAS DEFLATING SLOWLY. DURING FURTHER INFLATIONS IT WAS NOTED THAT THE INDEFLATOR PRESSURE WAS NOT ABLE TO BE HELD. THE BALLOON WAS INFLATED 3 TIMES TO 14 ATMOSPHERES(ATM) FOR 15 SECONDS, 12 SECONDS AND THEN 20 SECONDS. NEGATIVE PRESSURE WAS HELD FOR APPROXIMATELY 10 SECONDS TO INFLATE THE BALLOON. THE BDC WAS REMOVED FROM THE PATIENT. IT WAS NOTED THAT THERE WAS POSSIBLY A HOLE IN THE BALLOON. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869924 ↗
• MalfunctionMar 21, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 70% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 3.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS JUST STARTING TO ADVANCE IN THE ANATOMY, AGAINST RESISTANCE OVER AN UNSPECIFIED GUIDE WIRE (GW) WHEN THE DISTAL SHAFT SEPARATED IN TWO PIECES OUTSIDE OF THE ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NEW NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588129 ↗
• MalfunctionDec 7, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY RCA WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND A NON-ABBOTT STENT WAS IMPLANTED. FOR POST-DILATATION THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER BDC WAS ADVANCED WITH RESISTANCE WITH THE ANATOMY NOTED AND INFLATED BUT IT RUPTURED DURING THE FIRST INFLATION AT 18 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 15934391 ↗
• MalfunctionOct 24, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY. THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS MET WITH ANATOMY DURING REMOVAL. ANOTHER BALLOON CROSSED AND DILATED THE LESION. AN UNSPECIFIED STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658983 ↗
• MalfunctionSep 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE SHAFT OF A 3.5X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS FOUND SEPARATED IN TWO PIECES EVEN BEFORE THE PACKAGE WAS OPENED. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422516 ↗
• MalfunctionAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, INFLATED ONE TIME TO 12 ATMOSPHERES (ATM) AND HELD FOR 10 SECONDS WHEN A RUPTURE OCCURRED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SAME SIZE NON-ABBOTT DEVICE WAS USED TO COMPLETE THE LESION DILATATION, FOLLOWED BY XIENCE STENT IMPLANTATION TO SUCCESSFULLY COMPLETE THE PROCEDURE NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212163 ↗
• MalfunctionJun 16, 2022Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT DURING AN INTERVENTION, THE 3.50 X 15MM TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE AND SUCCESSFULLY INFLATED; HOWEVER, UPON REMOVAL, THE BALLOON WAS FULLY DEFLATED, BUT APPEARED TO CHANGE SHAPE AND WAS DIFFICULT TO REMOVE FROM THE VESSEL. 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 14722591 ↗
• MalfunctionMay 3, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS UNSPECIFIED LESION THAT IS 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2.5X13MM NON-ABBOTT BALLOON AND A 2.50X38MM XIENCE SKYPOINT STENT WAS DEPLOYED. THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. RESISTANCE WITH ANATOMY WAS NOTED DURING ADVANCEMENT OF THE BDC. A NON-ABBOTT BALLOON WAS USED TO 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 14269188 ↗
• MalfunctionMar 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT UPON UNBOXING THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC), THE SHAFT OF THE CATHETER WAS NOTED TO BE SEPARATED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DAMAGE NOTED TO THE CHIPBOARD BOX OR DISPENSER HOOP. A NEW, SAME SIZE NC TREK 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 13876378 ↗
• InjuryMar 8, 2022Inflation Problem; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Inflation Problem; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HIGH DIAGONAL LEFT CORONARY ARTERY (LCA). TWO NON-ABBOTT STENTS WERE IMPLANTED. POST DILATATION WAS INTENDED TO BE PERFORMED USING A 3.5X15MM NC TREK AND THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. DURING ADVANCEMENT, THERE WAS RESISTANCE WITH THE ANATOMY. IT WAS NOTED TO BE KINKED, HOWEVER, THE ATTENDING PHYSICIAN ORDERED THE PERFORMING PHYSICIAN TO KEEP GOING. UNDER FLUOROSCOPY, THE BALLOON WAS WHERE IT SHOULD BE UNDER THE STENT, HOWEVER, THERE WAS NO INDICATION THE BALLOON INFLATED. AT THAT POINT, THE BALLOON WAS ATTEMPTED TO BE RETRIEVED WITHOUT RESISTANCE BUT ONLY THE HYPOTUBE AND SHORT PART OF THE CATHETER WERE REMOVED. ANOTHER MORE EXPERIENCED PHYSICIAN TRIED TO RETRIEVE THE BALLOON WITH A SNARE DEVICE BUT WAS UNSUCCESSFUL. AT THAT POINT, THERE WAS FLOW BUT NOT A BRISK FLOW. THE MARKERS WERE STILL VISIBLE SO THE PHYSICIAN PUT ANOTHER NON-ABBOTT STENT ON THE MARKERS TO COMPRESS THE BALLOON TO THE SIDE OF THE ARTERY. THE PATIENT STAYED THE NIGHT AND THE NEXT DAY PARTS OF THE CATHETER WERE RETRIEVED BY SNARE DEVICE BUT PARTS OF THE BALLOON EMBEDDED UNDER THE STENT REMAINED IN THE PATIENT AND WERE VISIBLE

  Patient problems: Device Embedded In Tissue or Plaque; Ischemia

  MAUDE report 13694903 ↗
• MalfunctionFeb 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE RAMUS CIRCUMFLEX (RCX) ARTERY. AFTER ADVANCING THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) TO THE LESION, DURING BALLOON INFLATION A LEAK OF CONTRAST WAS NOTED FROM THE SHAFT OF THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472559 ↗
• InjuryJan 21, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN AN UNSPECIFIED ARTERY. THE 3.5X8MM AND 3.5X15MM NC TREK BALLOON DILATATION CATHETERS (BDC) WERE INFLATED ONCE UP TO 10 ATMOSPHERES (ATMS) AND NEGATIVE WAS HELD FOR 5 SECONDS TO DEFLATE THE BALLOONS, HOWEVER, THE BALLOONS COULD NOT BE DEFLATED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE DEVICES WERE PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. CONTRAST MIX USED WAS PER INSTRUCTIONS FOR USE. THE DEVICES WERE WITHDRAWN FULLY INFLATED. THE PATIENT HAD NO FLOW IN THE ARTERY AND HYPOTENSION OCCURRED. ADENOSINE WAS ADMINISTERED INTRAVENOUSLY AND ANOTHER BALLOON WAS USED FOR POST DILATATION. VASOVAGAL SYCOPE ALSO OCCURRED THAT NEEDED TIME TO TREAT AND RECOVER WHICH CAUSED A DELAY IN THE PROCEDURE. THE PATIENT IMPROVED AND THERE WAS NO PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Syncope/Fainting

  MAUDE report 13315458 ↗
• MalfunctionJan 10, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE 3.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS DIPPED IN A BOWL OF WATER AND INFLATION WAS ATTEMPTED; HOWEVER, BUBBLES WERE NOTICED FROM THE TIP OF BDC. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214204 ↗