NC TREK 1012448-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08717648151828), received between Oct 10, 2016 and Apr 11, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LEFT CIRCUMFLEX LESION WITH 75% STENOSIS. A 2.75X15 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, THE BDC WAS BENDING. A NEW NC TREK RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE RETURNED DEVICE INDICATED THAT THE SUPPORT SKIVE/WIRE/BAYONET WAS SEPARATED 6 CM DISTAL TO THE OUTER MEMBER TO HYPOTUBE SEAL, HOWEVER, WAS HELD BY THE OUTER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846466 ↗
• MalfunctionNov 21, 2024Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DURING PREPARATION OF THE 2.75X15MM NC TREK BALLOON DILATATION CATHETER IT WAS OBSERVED THAT THE SHAFT WAS KINKED AND ATTEMPT WAS MADE TO STRAIGHT OUT THE DEVICE; HOWEVER, SEPARATED AT THE SHAFT. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752435 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.75X15MM NC TREK RX BALLOON DILATION CATHETER (BDC) THE SHAFT WAS NOTED TO BE SEPARATED UPON OPENING THE PACKAGING. THE DEVICE WAS REPLACED WITH ANOTHER NC TREK BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689625 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  IT WAS REPORTED DURING PREPARATION OF THE 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) THE SHAFT WAS NOTED TO BE SEPARATED. A NEW DEVICE BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18936785 ↗
• MalfunctionApr 11, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND MILD CALCIFICATION. THE 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS ATTEMPTED TO BE USED FOR POST-DILATATION, HOWEVER, THE PROXIMAL SHAFT WAS NOTED TO BE FRACTURED AND SEPARATED IN TWO PIECES. THERE WAS RESISTANCE DURING REMOVAL WITH THE GUIDING CATHETER BUT FORCE WAS NOT APPLIED. THE PROXIMAL SHAFT WAS SIMPLY WITHDRAWN. ANOTHER BALLOON WAS USED TO CONTINUE WITH 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 16718104 ↗
• MalfunctionOct 12, 2022Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 99% STENOSIS. THE 2.75X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY BEFORE USE. THE DEVICE WAS INSERTED AND THE BALLOON WAS ATTEMPTED TO BE INFLATED. HOWEVER, IT WAS OBSERVED THE BALLOON WOULD NOT INFLATE AND THE PRESSURE WOULD DROP ON THE INDEFLATOR. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. WHILE OUTSIDE THE ANATOMY, THE TECH ATTEMPTED TO INFLATE THE BALLOON. IT WAS THEN OBSERVED BLOOD AND CONTRAST WAS LEAKING OUT AT THE PROXIMAL END OF THE CATHETER. A NON-ABBOTT BDC 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 15592045 ↗
• MalfunctionAug 29, 2022Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance; Failure to Deflate; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE FIRST DIAGONAL (1ST) ARTERY. A 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION, HOWEVER THE BDC MET RESISTANCE WITH THE HT BMW UNIVERSAL II GUIDE WIRE (GW) AND BECAME STUCK ON THE GUIDE WIRE PREVENTING IT FROM REACHING THE TARGET LESION. THE BDC WAS INFLATED ONE TIME, CLOSE TO THE TARGET LESION, HOWEVER THE BALLOON DID NOT DEFLATE. DAMAGE WAS NOTED TO THE SHAFT OF THE BDC WHICH WAS PREVENTING THE BALLOON FROM DEFLATING. THE INFLATED BALLOON AND THE GUIDE WIRE WERE REMOVED FROM THE ANATOMY, AND A NEW ABBOTT GUIDE WIRE AND ABBOTT BALLOON WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 15317128 ↗
• MalfunctionJul 14, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A 2.75X15MM NC TREK BALLOON FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WITH ANATOMY WAS ALSO MET. A NON-ABBOTT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021823 ↗
• MalfunctionMay 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. THE 2.75 X 15MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE FIRST INFLATION TO 18 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A 3.0X12MM NC TREK BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14294760 ↗
• MalfunctionDec 8, 2021Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE RIGHT CORONARY ARTERY (RCA). THE 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION BUT DID NOT INFLATE. IT WAS NOTED THAT WHEN PRESSURE WAS RELEASED AND MADE NEGATIVE, BLOOD APPEARED IN THE HUB. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 12964866 ↗
• MalfunctionOct 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 99% STENOSED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. A 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND INFLATED ONE TIME TO THE RATED BURST PRESSURE (RBP) OF 18 ATMOSPHERES (ATM), WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED, AND A SAME SIZE NON-ABBOTT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12657239 ↗
• MalfunctionAug 4, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A 95% STENOSED, HEAVILY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE PROXIMAL DIAGONAL ARTERY. A 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE. THE BDC WAS REMOVED; HOWEVER, RESISTANCE WITH THE GUIDE CATHETER WAS FELT DURING REMOVAL AND FORCE WAS APPLIED. THE PROXIMAL SHAFT SEPARATED OUTSIDE THE PATIENT ANATOMY WHILE STILL ON THE GUIDEWIRE. THE SEPARATED DISTAL SHAFT WAS ABLE TO BE REMOVED BY TRAPPING IT INSIDE THE GUIDING CATHETER AND REMOVING THE WHOLE SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS TIME. THERE WERE NO REPORTED 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 12275133 ↗
• MalfunctionApr 19, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER OPENING A 2.75X15MM TREK BALLOON DILATATION CATHETER (BDC), IT WAS NOTED THAT ALTHOUGH THE DEVICE WAS PRESENT, THE BALLOON AND PROTECTIVE SHEATH WERE MISSING FROM THE DEVICE AND NOT FOUND ANYWHERE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AN UNSPECIFIED 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.

  Patient problems: Insufficient Information

  MAUDE report 11689225 ↗
• MalfunctionFeb 23, 2021Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. AFTER LASER ATHERECTOMY ON THE LESION, THE 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED, BUT BACKFLOW WAS NOTED AS THE NON-ABBOTT BLEEDBACK VALVE WAS NOT TIGHTENED ENOUGH. THE VALVE WAS TIGHTENED, AND THE BACKFLOW SUBSIDED. THE BDC WAS THEN ADVANCED, BUT THE SHAFT SEPARATED BECAUSE THE VALVE WAS TOO TIGHT. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11369429 ↗
• MalfunctionDec 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.75 X 15 MM NC TREK BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH A NEW BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11066864 ↗
• MalfunctionSep 17, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT RESISTANCE WAS FELT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE 2.75 X 15MM NC TREK BALLOON DILATION CATHETER. THE BDC WAS NOT USED AND WAS REPLACED WITH A NEW NC TREK BDC. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10551519 ↗
• MalfunctionFeb 10, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT MAIN (LM) TO THE PROXIMAL LEFT ANTERIOR ARTERY (PLAD). A KISSING BALLOON TECHNIQUE WAS DONE BY INFLATING A 2.75X15MM RX NC TREK BALLOON DILATATION CATHETER (BDC) IN THE LEFT CIRCUMFLEX AND A 4.0X15MM RX NC TREK BDC IN THE LM ¿ PLAD. BOTH BALLOONS WERE PRESSURIZED TO 8 ATMOSPHERES. BOTH BALLOONS WERE DEFLATED MULTIPLE TIMES AS THEY DEFLATED SLOWLY. WHILE RETRIEVING THE 4.0X15MM NC TREK, THE BALLOON GOT STUCK WITH THE NEWLY DEPLOYED 3.5X15MM XIENCE SIERRA STENT AND BROKE THE STENT INTO TWO PARTS. THE PROXIMAL PORTION OF THE SEPARATED STENT WAS RETRIEVED WITH THE BALLOON. A SNARE DEVICE WAS USED TO RETRIEVE THE DISTAL PORTION OF THE STENT. DURING RETRIEVAL, THE BROKEN STENT STRUTS CAUGHT AND EXPLANTED A 2.75X48MM XIENCE XPEDITION STENT THAT HAD BEEN IMPLANTED ON (B)(6) 2019 IN THE MLAD. A NEW UNSPECIFIED STENT WAS DEPLOYED TO COVER THE ENTIRE LAD. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687810 ↗
• MalfunctionOct 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX THAT WAS 90% STENOSED. THE LESION WAS PRE-DILATED WITH A TRAVELER BALLOON THEN A XIENCE SIERRA STENT WAS DEPLOYED. FOR POST-DILATATION, A 2.75X15MM NC TREK WAS USED, HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A NEW NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9253101 ↗
• MalfunctionOct 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS 100% STENOSED. DURING THE FIRST INFLATION, THE NC TREK BALLOON WAS INFLATED TO 16 ATMOSPHERES AND CONTRAST AGENT WAS FOUND LEAKING; A BALLOON RUPTURE WAS OBSERVED. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITHOUT ISSUE. ANOTHER NC TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215847 ↗
• MalfunctionOct 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT WAS 100% STENOSED. A 2.75 X 15 MM NC TREK BALLOON CATHETER WAS USED AND WAS INFLATED ONCE. HOWEVER, THE BALLOON RUPTURED AT 18 ATMOSPHERES. THE DEVICE DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT, AND NO OTHER DEVICE ISSUES WERE NOTED. ANOTHER 2.75 X 15 MM NC TREK BALLOON CATHETER 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 9210854 ↗
• MalfunctionAug 27, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-CALCIFIED, NON-TORTUOUS, 90% STENOSED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO POST-DILATE AN UNSPECIFIED STENT. THE BDC WAS INFLATED ONCE TO FOUR ATMOSPHERES, BUT THE BALLOON FAILED TO INFLATE AND WAS NOTED TO BE LEAKING. A NON-ABBOTT BDC 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 8937665 ↗
• MalfunctionAug 9, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT A 2.75 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION OF AN UNSPECIFIED STENT. AFTER THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES, THE BALLOON PARTIALLY DEFLATED, WHICH RESULTED IN RESISTANCE WITH AN UNSPECIFIED GUIDING CATHETER DURING REMOVAL. AFTER SEVERAL ATTEMPTS, THE BALLOON WAS WITHDRAWN INDEPENDENTLY AND ULTIMATELY DEFLATED. AN UNSPECIFIED BDC 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 8879976 ↗
• MalfunctionJun 5, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 75% STENOSED. A 2.75 X 15 MM NC TREK BALLOON CATHETER WAS USED FOR PRE-DILATATION AND MET INITIAL RESISTANCE WITH THE ANATOMY. DURING THE FIRST INFLATION, THE NC TREK BALLOON RUPTURED AT APPROXIMATELY 12 ATMOSPHERES. AN UNSPECIFIED SEMI-COMPLIANT BALLOON CATHETER WAS THEN USED FOR PRE-DILATATION AS WELL. THEREFORE, THE DEVICE WAS REPLACED WITH AN UNSPECIFIED NC TREK BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670289 ↗
• MalfunctionJan 22, 2019Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  IT WAS REPORTED THAT THE BALLOON OF A 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS FOUND TO BE DAMAGED AFTER UNPACKING. A CHECK FOR LEAKS WAS MADE; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED 2.75X15MM DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269225 ↗
• MalfunctionNov 12, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING REMOVAL/PREPARATION OF A 2.75X15MM NC TREK BALLOON DILATATION CATHETER FROM THE DISPENSER HOOP COIL, IT WAS NOTED THAT THE SHAFT WAS BROKEN INTO TWO PIECES. NO RESISTANCE WAS NOTED. THE DEVICE WAS NOT USED. ANOTHER 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. DEVICE ANALYSIS IDENTIFIED BLOOD ON THE HYPOTUBE AND IN BETWEEN THE BALLOON FOLDS AND IN THE HUB. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THE PHYSICIAN HAD INTERACTED WITH THE DEVICE WITH HIS GLOVED HANDS WHICH HAD BLOOD AND CONTRAST.

  Patient problems: No Patient Involvement

  MAUDE report 8061977 ↗