NC TREK 1012445-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648151644), received between Oct 7, 2016 and Sep 21, 2023 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED ONCE TO 12-14 ATMOSPHERES. THEN THE BALLOON WAS ATTEMPTED TO BE DEFLATED FOR 30 SECONDS; HOWEVER, THE BALLOON WOULD FAILED TO DEFLATE. THEREFORE, THE ENTIRE SYSTEM HAD TO BE REMOVED FROM THE PATIENT WITH THE BALLOON INFLATED. 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 17795954 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE WHEN A RUPTURE OCCURRED IN 10 SECONDS AT 11 ATMOSPHERES. ANOTHER MANUFACTURER'S BALLOON 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 17321807 ↗
• MalfunctionJul 26, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. ANOTHER, SAME SIZE NC TREK 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 15105964 ↗
• InjuryJul 14, 2022Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN NC TREK BALLOON WAS ADVANCED TO THE TARGET LESION, ALTHOUGH THERE WAS SOME RESISTANCE MET WITH ANATOMY. DURING THE FIRST INFLATION IT WAS NOTED THAT PRESSURE WOULD NOT HOLD AS THE BALLOON SHAFT HAD A LEAK WHICH CAUSED AN AIR EMBOLISM AND SHUTDOWN THE LAD ARTERY. MEDICATION WAS PROVIDED TO TREAT THE AIR EMBOLISM AND SHUTDOWN OF THE LAD ARTERY. AFTER THE PROCEDURE IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Obstruction/Occlusion

  MAUDE report 15015190 ↗
• MalfunctionJun 27, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED AND TORTUOUS 100% STENOSED RIGHT CORONARY ARTERY (RCA). THE 2.0 X 12 MM NC TREK DILATATION CATHETER WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED AND THE SDS WAS UNABLE TO CROSS. RESISTANCE WAS NOTED DURING REMOVAL, RELATED TO THE VESSEL AND LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838537 ↗
• MalfunctionApr 22, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL LEFT CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A 2.00 X 12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT DUE TO ANATOMICAL CHALLENGES. THEN DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED AFTER FIVE SECONDS. THEREFORE THE BDC WAS REMOVED FROM PATIENT AND DILATATION WAS PERFORMED WITH NON-ABBOTT BALLOON. THE TARGET LESION WAS SUCCESSFULLY TREATED WITH A 2.5.X15MM XIENCE SKYPOINT STENT. 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 14190708 ↗
• MalfunctionDec 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX). A 2X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION DUE TO THE ANATOMY. THE BDC WAS REMOVED WITH RESISTANCE MET FROM THE ANATOMY, AND A NON-ABBOTT DEVICE WAS 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 13003465 ↗
• MalfunctionJul 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID DIAGONAL ARTERY. THE NC TREK BALLOON CATHETER WAS ADVANCED TO THE LESION, BUT RUPTURED DURING THE FIRST INFLATION AT AN UNKNOWN ATMOSPHERE. THE PATIENT WAS TREATED WITH ANOTHER NC TREK. THERE WERE NO REPORTED 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 12204012 ↗
• MalfunctionJan 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. THE 2.0X12MM NC TREK BALLOON RUPTURED AT 13ATM FOR 10 SECONDS ON THE FIRST INFLATION. THE BALLOON WAS REPLACED WITH A NEW NC TREK 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 11135232 ↗
• MalfunctionDec 15, 2020Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE LEFT CIRCUMFLEX (CX) CORONARY ARTERY, 90% STENOSED LESION. AN UNSPECIFIED STENT WAS IMPLANTED AND A 2.0X12MM NC TREK BALLOON DILATATION CATHETER ADVANCED WITHOUT RESISTANCE FOR POST-DILATATION. DURING THE INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE NC TREK WAS REMOVED WITHOUT REPORTED ISSUES AND ANOTHER DEVICE, SAME SIZE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11013011 ↗
• MalfunctionJun 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 2.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE; HOWEVER, THE BALLOON RUPTURED AT A LOW-PRESSURE DURING USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. 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 10184386 ↗
• MalfunctionApr 14, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT A 2.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, THE SHAFT SEPARATED. THE BDC WAS REMOVED. A 2.0X15MM NC TREK RX BDC WAS ADVANCED AND AGAIN THE SHAFT SEPARATED. THE BDC WAS REMOVED. IN BOTH CASES, THE SEPARATIONS MADE IT MORE COMPLEX DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957572 ↗
• MalfunctionFeb 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON CATHETER WAS ADVANCED TO THE LESION AND DURING USE RUPTURED AT 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747146 ↗
• MalfunctionJan 14, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED DE NOVO LESION, IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. RESISTANCE WAS FELT WITH THE ANATOMY WHEN ADVANCING THE 2.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) TO THE TARGET LESION FOR PRE-DILATATION AND DURING THE FIRST INFLATION TO 18 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BDC. 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 9589506 ↗
• MalfunctionNov 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TYVEK POUCH OF A 2.0X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS OPENED; HOWEVER, IT WAS NOTED THAT THE PROXIMAL SHAFT OF THE BDC WAS SEPARATED. THE BDC WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED NC 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 9376293 ↗
• MalfunctionNov 7, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 2.0 X 12MM NC TREK BALLOON MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT BUT WAS ABLE TO REACH THE LESION. THEN ONCE INFLATED THE BALLOON RUPTURED AT 18 ATMOSPHERES. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291758 ↗
• MalfunctionOct 15, 2019Break; Material Separation; Noise, Audible; Break; Material Separation; Noise, Audible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED UNSPECIFIED CORONARY ARTERY. A 2.0 X 12 MM NC TREK BALLOON CATHETER WAS USED; HOWEVER, IT BECAME "DAMAGED/BROKEN" DURING PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS ADDED. THE DEVICE MADE A POPPING SOUND DURING A KISSING BALLOON TECHNIQUE AND THE SHAFT OF THE NC TREK BALLOON CATHETER SEPARATED IN THE HEMOSTATIC VALVE. THE COMPONENTS WERE SIMPLY WITHDRAWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194704 ↗
• MalfunctionAug 26, 2019Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE DISTAL LEFT MAIN INTO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BDC WAS ADVANCED TO THE LESION; HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 19 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER AND THE DEPLOYMENT OF AN UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: ACCORDING TO THE REPORTING, THIS ELDERLY MALE WAS UNDERGOING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) FOR STENTING OF THE LEFT MAIN AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. PATIENT PREVIOUSLY HAD CORONARY ARTERY BYPASS GRAFT (CABG) X3, FOLLOWING STANDARD INSERTION OF THE NC TREK RX BALLOON INTO THE LEFT MAIN ARTERY DURING INFLATION OF THE BALLOON AT 19 ATMS FOR 43 SECONDS THE BALLOON WAS NOTED TO RUPTURE. THE DEVICE WAS REMOVED WITHOUT INCIDENT AND INSPECTED. THE BALLOON WAS DEEMED TO BE INTACT BY THE PHYSICIAN AND THE CATH LAB STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8931842 ↗
• MalfunctionMay 16, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN ATTEMPTING TO REMOVE THE PROTECTIVE SHEATH OFF A 2.0X12MM NC TREK RX BALLOON DILATATION CATHETER. THE STYLET WAS ABLE TO BE REMOVED. EXCESSIVE FORCE WAS NEEDED TO SUCCESSFULLY REMOVE THE PROTECTIVE SHEATH, BUT THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8617786 ↗
• MalfunctionApr 26, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY TORTUOUS AND MILDLY CALCIFIED CONCENTRIC LESION IN THE BELOW BIFURCATION POSTERIOR DESCENDING CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC), A 2.0 X 12 MM NC TREK RX BDC WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE CALCIFIED LESION DURING ADVANCEMENT. DURING THE FOURTH INFLATION OF THE NC TREK RX BDC, THE BALLOON RUPTURED AT 16 ATMOSPHERES. THE NC TREK RX BDC WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT RESISTANCE. A NON-ABBOTT BDC WAS USED FOR ADDITIONAL PRE-DILATATION AND THE PROCEDURE WAS COMPLETED WITH A DRUG COATED BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558086 ↗
• MalfunctionFeb 18, 2019Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.0X22MM NON-ABBOTT STENT WAS DEPLOYED. A 2.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED FOR POST-DILATATION; HOWEVER, RESISTANCE WAS FELT WITH THE DEPLOYED STENT. THE PROXIMAL SHAFT OF THE BDC SEPARATED OUTSIDE THE GUIDING CATHETER. THE BDC WAS REMOVED WITHOUT ISSUES AND 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 8348720 ↗
• MalfunctionDec 21, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED, ECCENTRIC AND DE NOVO DISTAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. DURING PRE-DILATATION, A 2.0 X 12 NC TREK BALLOON CATHETER WAS INFLATED ONCE TO 6 ATMOSPHERES FOR 10 SECONDS WHEN IT RUPTURED. THE BALLOON CATHETER WAS PREPPED BEFORE USE PER THE INSTRUCTIONS FOR USE. THERE WAS NO RESISTANCE MET DURING ADVANCEMENT OR REMOVAL OF THE BALLOON CATHETER AND NO OTHER REPORTED ISSUES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE PRE-DILATATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138956 ↗
• MalfunctionDec 13, 2017Break

  IT WAS REPORTED THE BALLOON OF THE NC TREK 2.0X12 BROKE AT THE DISTAL END. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7115436 ↗
• MalfunctionMay 26, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION IN THE MODERATELY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.00 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR THE PROCEDURE. THE BDC WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND WHEN INFLATED THE SECOND TIME TO 18 ATMOSPHERES THE BALLOON RUPTURED. THE BDC WAS REMOVED WITH NO RESISTANCE FROM THE ANATOMY AND WAS REPLACED WITH A 2.25 X 12 MM NC TREK BDC TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596053 ↗
• MalfunctionApr 13, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 2.0 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) TO THE LESION FOR PRE-DILATATION; HOWEVER, IT WAS ABLE TO CROSS SUCCESSFULLY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A NEW BDC WAS USED AND THE PROCEDURE WAS COMPLETED AFTER A STENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488979 ↗