NC TREK 1012447-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08717648151743), received between Aug 22, 2016 and Jul 1, 2025 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION RESTENOSIS IN THE LEFT CIRCUMFLEX (CX). THE 2.5X8.0MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ATTEMPTED TO BE USED FOR VESSEL PRE-DILATATION; HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 11 BAR [APPROXIMATELY 12ATMOSPHERES]. THE BDC WAS REMOVED AND A 2.5X8MM NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375136 ↗
• MalfunctionFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. WHEN ATTEMPTING TO INFLATE THE 2.5X8MM NC TREK BALLOON DILATATION CATHETER A BALLOON RUPTURE OCCURRED AT 10 ATMOSPHERES. A NEW NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759827 ↗
• InjuryMay 4, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 90% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY. A 2.0X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION, HOWEVER, IT COULD NOT BE FULLY INFLATED DUE TO THE CALCIFICATION IN THE LESION. A 2.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION AND INFLATED TO 20 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED A HEMATOMA FROM THE LCX TO THE LEFT MAIN (LM) CORONARY ARTERY. A 2.75X15MM XIENCE ALPINE DRUG ELUTING STENT (DES) WAS IMMEDIATELY IMPLANTED INTO THE LCX OSTIUM TO PREVENT FURTHER TEARING OF THE HEMATOMA. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 16869292 ↗
• MalfunctionMar 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION, THE 2.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 9 ATMOSPHERES (ATM) AFTER 10 SECONDS. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. PRIOR TO USE, THE BDC WAS SOAKED IN SALINE AND PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THERE WAS NO RESISTANCE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. A SAME SIZE NON-ABBOTT BDC WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630973 ↗
• MalfunctionJan 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 75% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. ANOTHER DEVICE WAS USED TO CONTINUE 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 16090096 ↗
• MalfunctionNov 7, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). 2.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY. THE BDC RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER SAME SIZE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749561 ↗
• MalfunctionAug 22, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. AFTER A GUIDE WIRE CROSSED THE LESION, THE 2.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND WAS CONFIRMED WITH CINE TO HAVE CONTRAST MEDIUM LEAKING JUST BEFORE REACHING NOMINAL PRESSURE. THE BALLOON WAS INFLATED ONCE AT APPROXIMATELY 6 ATMOSPHERES (ATMS) FOR APPROXIMATELY 5 SECONDS. THE INDEFLATOR DEVICE ALSO STOPPED INCREASING PRESSURE AND WHEN THE BDC WAS REMOVED FROM THE ANATOMY, THE DISTAL PART OF THE BALLOON WAS NOTED TO BE RUPTURED. THERE WAS NO RESISTANCE DURING REMOVAL. THE BDC WAS SOAKED IN SALINE AND THE DEVICE WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. NO RESISTANCE WAS MET WHEN THE PROTECTIVE SHEATH WAS REMOVED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE 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 15265245 ↗
• MalfunctionJul 18, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING LESION THAT WAS 90% STENOSED. A 2.5X8MM NC TREK BALLOON FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WAS ALSO MET WITH ANATOMY. 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 15042409 ↗
• MalfunctionMay 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, WITHOUT ISSUE. DURING PRE-DILATATION, THE BALLOON RUPTURED ON THE FIRST INFLATION TO 12 ATMOSPHERES (ATM). 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 BALLOON WAS USED TO SUCCESSFULLY PRE-DILATATE THE LESION FOR STENT IMPLANTATION TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519754 ↗
• MalfunctionJan 26, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT A 2.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED FROM THE PACKAGING WITHOUT ISSUE; HOWEVER, THE PROTECTIVE SHEATH STUCK TO THE BDC WHEN ATTEMPTING TO REMOVE IT AND THE SHAFT SEPARATED. ANOTHER NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358104 ↗
• MalfunctionDec 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY DISTAL RIGHT CORONARY ARTERY THAT IS 99% STENOSED. A NON-ABBOTT SEMI-COMPLIANT BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO PRE-DILATE THE LESION; HOWEVER, THE BDC RUPTURED. A 2.5X8MM NC TREK BDC WAS USED TO PRE-DILATE, BUT RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. A NON-ABBOTT BDC WAS USED TO CONTINUE AND A ROTABLATOR WITH A DRUG COATED BALLOON 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 12965110 ↗
• MalfunctionAug 11, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5X8 MM NC TREK BALLOON WAS INFLATED TWICE TO 20 ATMOSPHERES AND RUPTURED. ANOTHER SAME SIZE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308575 ↗
• MalfunctionMar 16, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. THE NC TREK BALLOON FAILED TO CROSS AND WAS DIFFICULT TO REMOVE FROM THE ANATOMY. ANOTHER NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11499858 ↗
• MalfunctionOct 2, 2020Difficult to Insert; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Insert; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 99% STENOSED AND MODERATELY TORTUOUS LESION IN THE LEFT MAIN ARTERY TO THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING PRE-DILATATION, ST ELEVATION WAS NOTED. ASPIRATION WAS PERFORMED WITH A THROMBECTOMY DEVICE AND MEDICATION WAS ADMINISTERED. THE ST ELEVATION WAS STILL SLIGHTLY NOTED. THREE XIENCE SIERRA STENTS (2.25X38MM, 3.0X38MM, AND 3.5X23MM) WERE DEPLOYED IN THE MID LAD TO THE LEFT MAIN ARTERY FROM THE DISTAL SIDE. PROXIMAL OPTIMIZATION TECHNIQUE WAS ALSO PERFORMED IN THE MID LAD AND PROXIMAL LAD WITH 3.25MM NON-ABBOTT BALLOON CATHETER. FOR KISSING BALLOON TECHNIQUE OF THE LAD ARTERY AND THE 1ST DIAGONAL ARTERY, A 2.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS CHOSEN. THE BDC WAS PREPARED; HOWEVER, THE STYLET WAS NOT REMOVED BEFORE PREP. ADDITIONALLY, RESISTANCE WAS NOTED WHEN REMOVING THE STYLET FROM THE BDC. AN ATTEMPT WAS MADE TO INSERT THE BDC ONTO A NON-ABBOTT GUIDE WIRE; HOWEVER, THE BDC FAILED TO BE INSERTED ONTO THE GUIDE WIRE. IT WAS THOUGHT THAT THE LUMEN OF THE BDC COLLAPSED DURING REMOVAL OF THE STYLET. THE BDC WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.5X6MM NON-AB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10623042 ↗
• MalfunctionJun 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS DE NOVO MID-LEFT CIRCUMFLEX. THE 2.50X8MM NC TREK BALLOON RUPTURED AT 6ATM ON THE FIRST INFLATION. THE DEVICE WAS REPLACED WITH A NEW 2.5X12MM NC TREK BALLOON TO SUCCESSFULLY CONTINUE 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 10146123 ↗
• MalfunctionMar 11, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BEFORE USE OF A 2.5X8MM NC TREK BALLOON, IT WAS NOT POSSIBLE TO REMOVE THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW 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 Patient Involvement

  MAUDE report 9819564 ↗
• MalfunctionFeb 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. DURING USE, THE NC TREK BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742433 ↗
• MalfunctionFeb 14, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING UNPACKAGING OF THE 2.50 X 8MM NC TREK BALLOON DILATATION CATHETER (BDC) THE YELLOW PROTECTIVE BALLOON SHEATH COULD NOT BE REMOVED. THE BDC WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9712939 ↗
• MalfunctionJan 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. THE NC TREK WAS ATTEMPTED TO PERFORM PRE-DILATATION OF THE TARGET LESION BUT RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES, DESPITE BEING PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE NC TREK WAS REPLACED WITH A NON-ABBOTT BALLOON TO PERFORM PRE-DILATATION WITHOUT ISSUES. THEN, A STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565085 ↗
• MalfunctionNov 19, 2019Inflation Problem; Stretched; Inflation Problem; Stretched

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9344966 ↗
• MalfunctionSep 22, 2019Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Packaging Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE, A 3 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) AND A 2.5 X 8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WERE FOUND KINKED ALONG WITH THE DISPENSER HOOPS. THE BDC FELT RESISTANCE REMOVING THE PROTECTIVE SHEATH AND WAS ATTEMPTED TO BE USED. HOWEVER, THE BALLOON DID NOT INFLATE DESPITE HOLDING PRESSURE. THE SDS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW UNSPECIFIED BDC AND SDS WERE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9102195 ↗
• MalfunctionSep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, HEAVILY CALCIFIED LESION IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS PLACED IN THE TARGET LESION. A 2.50X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE LESION FOR POST-DILATATION. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS. THE BDC WAS REMOVED WITHOUT RESISTANCE AND A NEW SAME SIZE NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846819 ↗
• MalfunctionMay 22, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, CONCENTRIC AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS 99% STENOSED. PRE-DILATATION AT THE MID LAD WAS PERFORMED WITH A 1.2 X 6 MM MINI TREK BALLOON DILATATION CATHETER (BDC). THE FIRST INFLATION WAS DONE AT 10 ATMOSPHERES (ATMS), THE SECOND AT 12 ATMS; HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 12 ATMS. THEREFORE, A 2.5 X 15 MM TREK BDC WAS USED IN THE PROXIMAL LAD AND WAS INFLATED AT 12 ATMS; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMS. A 2.5 X 8 MM NC TREK BDC WAS THEN USED AND INFLATED AT 16 ATMS; HOWEVER, THE BALLOON RUPTURED AT 18 ATMS DURING THE SECOND INFLATION. THE DEVICES DID NOT MEET ANY RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT. THE 2.5 X 8 MM NC TREK BDC WAS THEN REPLACED WITH A NON-ABBOTT BDC AND A XIENCE SIERRA STENT WAS IMPLANTED 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 7531915 ↗
• MalfunctionApr 4, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE 2ND OBTUSE MARGINAL CORONARY. A 2.50 X 8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR POST-DILATATION OF AN UNSPECIFIED STENT IMPLANT. THE BDC WAS ADVANCED TOWARD THE LESION WITH NO RESISTANCE FELT AND DURING ADVANCEMENT, THE PROXIMAL SHAFT SEPARATED NEAR THE HUB OUTSIDE THE ANATOMY. AS THE SEPARATION WAS OUTSIDE THE ANATOMY, THE BDC WAS EASILY REMOVED FROM THE ANATOMY. A NEW 2.00 X 8 MM NC TREK RX WAS USED TO SUCCESSFULLY COMPLETE THE POST-DILATATION. 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 7397771 ↗
• MalfunctionMay 18, 2017Material Rupture; Improper or Incorrect Procedure or Method

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6575537 ↗