NC TREK 1012450-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08717648151934), received between Aug 4, 2016 and Jun 23, 2023 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 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.

• MalfunctionJun 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS MILDLY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON WAS USED TO PRE-DILATE THE LESION BUT RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195192 ↗
• MalfunctionJun 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURED OCCURRED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042282 ↗
• MalfunctionJun 1, 2023Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.25X15MM NC TREK BALLOON DILATATION CATHETER WAS NOTED TO BE KINKED; HOWEVER, WAS INSERTED IN THE PATIENT ANATOMY. THE DEVICE SEPARATED AND NOTED NO PIECES REMAINED IN THE ANATOMY. ANOTHER 3.5 NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035772 ↗
• MalfunctionMar 24, 2023Difficult 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 DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE BDC WAS FLUSHED AND PREPARED PER INSTRUCTION FOR USE (IFU), HOWEVER, THERE WAS RESISTANCE WHEN PROTECTIVE SHEATH WAS REMOVED. THE BDC HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND WAS INFLATED TWO TIMES, BOTH AT 21 ATMOSPHERES (ATMS). THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 21 ATMS FOR FIVE SECONDS. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. THE BDC WAS REMOVED INDEPENDENTLY. 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 16612160 ↗
• MalfunctionFeb 7, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF THE NC TREK BALLOON DILATATION CATHETER (BDC) AND THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), THE DEVICES WERE NOTED TO BE DAMAGED. THE SHAFT OF THE NC TREK WAS BROKEN AND IN TWO SEPARATE PIECES AND THE DISTAL TIP OF THE XIENCE SKYPOINT SDS WAS FRAYED. ANOTHER NC TREK BDC AND XIENCE SKYPOINT SDS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE NC TREK SHOWED SIGNS OF USE. THE ACCOUNT CONFIRMED THAT THE DEVICE WAS ATTEMPTED TO BE USED BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE BALLOON CATHETER CAUGHT ON SOME CALCIUM IN THE VESSEL AND THE PHYSICIAN HAD TO PULL ON IT TO GET IT OUT AND IT SEPARATED. THE DEVICE WAS REMOVED WITH NO HARM TO 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 16312710 ↗
• MalfunctionOct 12, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA). FOLLOWING STENT IMPLANTATION, THE 3.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION FOR POST-DILATATION; HOWEVER THE BDC COULD NOT ADVANCE BEYOND THE STRUT OF THE PREVIOUSLY IMPLANTED STENT. THE SHAFT OF THE BDC SNAPPED IN MORE THAN ONE PIECE OUTSIDE THE ANATOMY NEAR THE BDC HUB. SINCE, THE BREAK OCCURRED OUTSIDE THE ANATOMY THE BDC WAS ABLE TO BE REMOVED WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE NC TREK BALLOON WAS USE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592255 ↗
• MalfunctionAug 10, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION THE CIRCUMFLEX ARTERY. THE UNSPECIFIED BMW GUIDE WIRE (GW) WAS POSITIONED IN THE VESSEL AND AFTER STENT IMPLANTATION, A 3.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE WIRE, BUT BECAME STUCK ON THE WIRE. THE BDC COULD BE RETRACTED WITH DIFFICULTY, BUT THE BDC AND GW WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. ANOTHER GW AND BALLOON WERE USED FOR POST-DILATATION TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15205032 ↗
• MalfunctionMar 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE MID-RIGHT CORONARY ARTERY (RCA). A 3.25X15MM NC TREK BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION AND WAS INFLATED 1 TIME TO 10 ATMOSPHERES (ATM) FOR 10 SECONDS, WHEN A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO PRE-DILATATE, AFTER WHICH A 3.5X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727376 ↗
• MalfunctionSep 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREP, THE PROTECTIVE SHEATH WAS BEING REMOVED FROM A 3.25X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WHEN RESISTANCE WAS NOTED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. 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 12558183 ↗
• MalfunctionMay 21, 2021Leak/Splash; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Leak/Splash; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE 3.25 X 15 MM NC TREK DILATATION CATHETER WAS REMOVED FROM THE HOOP WITHOUT ISSUE. THE DEVICE WAS COILED TO PLACE ON THE BACK TABLE FOR DEVICE PREPARATION. IT WAS NOTED TO HAVE A KINK IN THE HYPOTUBE, THOUGHT TO HAVE OCCURRED DURING COILING. THE KINK WAS STRAIGHTENED AND THE DEVICE WAS PREPPED. AN AIR LEAK WAS NOTED AND THE DEVICE WAS STRAIGHTENED AGAIN; HOWEVER, THE DEVICE THEN SNAPPED INTO TWO PIECES. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867728 ↗
• MalfunctionMay 6, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.25X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUES. THE BDC WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. ONCE AT THE TARGET LESION THE BALLOON WAS INFLATED 2-3 TIMES AT 16-18 ATMOSPHERES (ATMS). THE BALLOON RUPTURED AT 18 ATMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. 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 11787974 ↗
• MalfunctionMar 15, 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 DURING PREPARATION OF THE 3.25X15 NC TREK, THE BALLOON WAS REMOVED FROM THE HOOP, BUT THE STYLET WAS NOTICED TO BE STUCK INSIDE THE BALLOON CATHETER. ADDITIONAL FORCE WAS APPLIED TO REMOVE THE STYLET. IT WAS NOTED THAT WHEN REMOVING THE STYLET, THE ORANGE TIP AT THE END OF THE BALLOON HAD BEEN PULLED OFF. THE DEVICE WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11484328 ↗
• MalfunctionFeb 22, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. THE NC TREK BALLOON DILATATION CATHETER WAS ADVANCED AGAINST SOME RESISTANCE TO THE LESION AND RUPTURED DURING INFLATION AT 8 ATMOSPHERES (ATM). THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11363310 ↗
• MalfunctionDec 15, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020 A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE MODERATELY TORTUOUS, MID LEFT ANTERIOR DESCENDING (LAD), HEAVILY CALCIFIED LESION. THE 3.25X15MM NC TREK DILATATION CATHETER ADVANCED TO THE LESION WITH RESISTANCE NOTED DUE TO ANATOMY. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE.THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE 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 11013032 ↗
• MalfunctionMar 31, 2020Material 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 CALCIFIED, MILDLY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT WAS 80% STENOSED. THE 3.25X15MM NC TREK BALLOON WAS INFLATED A FEW TIMES (EXACT NUMBER NOT GIVEN) AT 20 ATMOSPHERES (ATM) THEN THE BALLOON RUPTURED AT 20 ATM. A NEW 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: No Consequences Or Impact To Patient

  MAUDE report 9904437 ↗
• MalfunctionMar 4, 2020Product Quality Problem; Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Product Quality Problem; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX. A 3.25X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS DAMAGED WHILE TRYING TO CROSS. THE METHOD USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT EFFECTS. DURING INVENTORY OF THE RETURNED DEVICE, A HYPOTUBE SEPARATION WAS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788144 ↗
• MalfunctionFeb 12, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. THE NC TREK BALLOON DILATATION CATHETER WAS ADVANCED WITH RESISTANCE, AND RUPTURED DURING THE SECOND INFLATION AT 16 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED 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 9703149 ↗
• MalfunctionFeb 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TREATING AN OBTUSE MARGINAL CORONARY ARTERY WITH MODERATE CALCIFICATION. AN NC TREK DILATATION CATHETER ADVANCED WITHOUT ISSUE AND POST-DILATATION WAS PERFORMED ON AN UNSPECIFIED STENT. DURING NC TREK REMOVAL, THERE WAS NO UNUSUAL RESISTANCE FELT, HOWEVER, THE BALLOON WAS OBSERVED SEPARATED FROM THE SHAFT. REPORTEDLY, THIS WAS SURPRISING AS THERE WAS NO UNUSUAL RESISTANCE EXPERIENCED. THE GUIDE CATHETER AND NC TREK WERE REMOVED AS A SINGLE UNIT. THE SEPARATED BALLOON HAD REMAINED IN THE GUIDE CATHETER AND NOTHING WAS LEFT IN THE ANATOMY. THE PATIENT REMAINED IN STABLE CONDITION. THERE WAS NO ADVERSE PATIENT EFFECT 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 9672964 ↗
• MalfunctionDec 20, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED MODERATELY TORTUOUS DE NOVO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. THE 3.25X15MM NC TREK BALLOON DILATATION CATHETER MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE BALLOON RUPTURED AT 12 ATMOSPHERES ON THE SECOND INFLATION. 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 Consequences Or Impact To Patient

  MAUDE report 9507400 ↗
• MalfunctionDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED, MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.25X15 MM NC TREK BALLOON DILATATION CATHETER BURST DURING INFLATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414108 ↗
• MalfunctionJun 20, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED CONCENTRIC DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. FOLLOWING DILATATION WITH A SEMI-COMPLIANT BALLOON, RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT OF A 3.25 X 15MM NC TREK BALLOON DILATATION CATHETER (BDC) AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT AROUND 14 ATMOSPHERES. PRIOR TO USE, THE BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT NON-COMPLIANT BDC. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717216 ↗
• MalfunctionJun 19, 2019Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING DEVICE PREPARATION THE NC TREK DILATATION CATHETER HAD KINKED PULLING FROM THE HOOP. IT THEN SEPARATED UPON ENTERING INTO THE HEMOSTASIS VALVE. THE DEVICE WAS SET ASIDE FOR RETURN AND NOT USED FURTHER. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED 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 8713617 ↗
• MalfunctionJun 15, 2018Detachment Of Device Component; Inflation Problem

  IT WAS REPORTED THAT THE 3.25X15 MM NC TREK WAS ADVANCED TO THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY AND ATTEMPT WAS MADE TO INFLATE THE NC TREK, BUT IT WOULD NOT INFLATE. IT WAS NOTED AT THAT TIME THAT THE HUB OF THE NC TREK WAS NOT ATTACHED TO THE PROXIMAL SEGMENT OF THE NC TREK. THE HUB WAS STILL CONNECTED TO THE INFLATION DEVICE, BUT THE CATHETER ITSELF WAS NOT CONNECTED TO THE HUB. NO AIR ENTERED THE ANATOMY. THE NC TREK WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A NEW, SAME SIZE NC TREK, WHICH WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7605708 ↗
• MalfunctionJun 8, 2018Deflation Problem

  PATIENT ADMITTED AS ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) FROM ER FOR A LEFT HEART CATHETERIZATION AND POSSIBLE INTERVENTION. NC TREK BALLOON INFLATED BY INTERVENTIONAL PHYSICIAN AND DID NOT DEFLATE. EVENT HAPPENED EARLY IN THE MORNING. BALLOON STAYED INFLATED FOR 107 SECONDS AT 14 ATM TO MID LAD LESION. INTERVENTIONAL PHYSICIAN INFLATED BALLOON TO 30 ATM IN ATTEMPT TO RUPTURE BALLOON, THEN DISCONNECTED AND RECONNECTED INFLATION DEVICE. BALLOON DEFLATED. NO VITAL SIGNS CHANGES DURING THIS EVENT. PATIENT DID NOT COMPLAIN OF PAIN OR DISCOMFORT. PCI SUCCESSFULLY COMPLETED. PATIENT TRANSFERRED TO CCU BY RN AND DOCTOR WITH NO ISSUES. DEVICE SAVED TO BE EXAMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7582087 ↗
• MalfunctionFeb 21, 2018Difficult to Remove; Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, AND DE NOVO MID RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. AN UNSPECIFIED GUIDEWIRE ADVANCED TO THE LESION, BUT A 1.5 X 6 MM RX MINI TREK BALLOON CATHETER MET RESISTANCE DURING ADVANCEMENT AND COULD NOT CROSS DUE TO THE ANATOMY. THE MINI TREK BALLOON CATHETER WAS REMOVED WITH RESISTANCE AND REPLACED WITH A NON-ABBOTT BALLOON CATHETER. THEN THE LESION WAS PRE-DILATATED WITH A NON-ABBOTT BALLOON, AND A 3.25 X 15 MM NC TREK BALLOON WAS USED FOR FURTHER DILATATION. THE NC TREK BALLOON MET RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY, BUT REACHED THE TARGET LESION AND DURING FIRST INFLATION THE NC TREK BALLOON RUPTURED AT 10 ATMOSPHERES. THE NC TREK BALLOON WAS REMOVED WITH RESISTANCE DUE TO THE ANATOMY. A ROTABLATOR AND AN UNSPECIFIED XIENCE STENT WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286481 ↗