NC TREK 1012450-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08717648151927), received between Aug 11, 2016 and Jun 26, 2023 — classified as 2 injuries, 32 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN CORONARY ARTERY. THE 3.25X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED; HOWEVER, IF WAS NOTED THAT IT DID NOT ACQUIRE ADEQUATE PRESSURE AND WAS PERFORATED. 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 17199913 ↗
• MalfunctionApr 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 3.25X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PLAIN OLD BALLOON ANGIOPLASTY (POBA) AND A RUPTURE OCCURRED AFTER THE FIRST INFLATION AT 13 ATMOSPHERES. 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 16718088 ↗
• MalfunctionNov 9, 2022Difficult 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 LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE 3.25X12MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED AGAINST RESISTANCE TO THE LESION. DURING THE FIRST INFLATION TO 14 ATMOSPHERES THE BALLOON RUPTURED. RESISTANCE WAS NOTED DURING REMOVAL OF THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH DILATATION USING A CUTTING BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765210 ↗
• MalfunctionOct 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION. PRIOR TO USE THE 3.25X12MM NC TREK BALLON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE PATIENT ANATOMY. THE BDC WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 12 ATMOSPHERES; HOWEVER, DURING THE SECOND INFLATION TO NOMINAL PRESSURE THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656007 ↗
• MalfunctionAug 29, 2022Difficult 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 HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT. THE BDC RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES AND DURING REMOVAL RESISTANCE WAS MET WITH ANATOMY. IT IS UNKNOWN IF ANOTHER DEVICE WAS USED TO 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 15314217 ↗
• MalfunctionAug 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND 75% STENOSED. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON, A NON-ABBOTT STENT WAS IMPLANTED. AN NC TREK WAS ADVANCED FOR POST-DILATATION AND ATTEMPTED TO INFLATE AT THE NOMINAL PRESSURE WHEN A RUPTURE OCCURRED. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SAME SIZE NON-ABBOTT WAS APPLIED FOR POST-DILATATION AS A REPLACEMENT DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288112 ↗
• MalfunctionJun 2, 2022Difficult 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 HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE FORM THE ANATOMY AND INFLATED ONE TIME TO 12 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. 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 14579807 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS FIRST OBTUSE MARGINAL ARTERY THAT IS 90% STENOSED. THE 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD BEEN FULLY DEFLATED, BUT WAS STUCK WITH THE 014 HI-TORQUE TURNTRAC FLEX GUIDE WIRE AS BDC WAS MOVED. THE GUIDE WIRE AND THE BALLOON WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER NC TREK WAS USED WITH A NON-ABBOTT GUIDE WIRE 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 13155540 ↗
• 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, LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.25X12MM 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 13006647 ↗
• MalfunctionNov 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) THAT IS 90% STENOSED. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED DEVICE AND UNSPECIFIED DRUG ELUTING STENT WAS DEPLOYED. POST-DILATATION WAS ATTEMPTED WITH A 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC); HOWEVER, THE BDC RUPTURED AT 16 ATMOSPHERES (ATM) DURING THE SECOND INFLATION FOR 15 SECONDS. THE BDC WAS FIRST INFLATED TO 14 ATMS. AFTER THE BDC WAS REMOVED, IT WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND (IVUS) THAT THE STENT WAS FULLY EXPANDED AND NO ADDITIONAL DEVICE WAS NEEDED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12835944 ↗
• MalfunctionJun 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED MID RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5X15MM TREK BALLOON, AND AN UNSPECIFIED 3X15MM STENT WAS IMPLANTED WITH THE USE OF A NON-ABBOTT GUIDE WIRE AND NON-ABBOTT 6F GUIDE CATHETER. A 3.25X12MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED ON THE SECOND INFLATION AT 18 ATMOSPHERES. 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 12067285 ↗
• MalfunctionNov 16, 2020Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING NC TREK PREPARATION, THE PROTECTIVE SHEATH AND STYLET WERE REMOVED WITHOUT ISSUE. DEVICE PREPARATION WAS PERFORMED PER INSTRUCTIONS FOR USE (IFU), WHEN THE BALLOON APPEARED ¿FRAIL¿ AND SEPARATED IN HALF WHILE HANDLING. THE DEVICE WAS SET ASIDE AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER DEVICE WAS USED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10848566 ↗
• MalfunctionOct 2, 2020Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A HEAVILY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, AS A 3.25X12MM RX NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED, RESISTANCE WAS NOTED WITH THE ANATOMY AND THE GUIDE CATHETER. THE SHAFT BENT WHILE ADVANCING THROUGH THE GUIDING CATHETER AND THE BALLOON NEVER REACHED THE LESION. THE BDC WAS WITHDRAWN WITH RESISTANCE NOTED WITH THE GUIDING CATHETER. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER UNSPECIFIED DEVICE SUCCESSFULLY COMPLETED THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621831 ↗
• MalfunctionJan 8, 2020Leak/Splash; Difficult to Remove; Material Separation; Leak/Splash; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS DE NOVO PROXIMAL CIRCUMFLEX LESION. THE 3.25X12MM RX NC TREK BALLOON DILATATION CATHETER (BDC) WAS PRESSURIZED, AND CONTRAST WAS NOTED IN THE UNSPECIFIED GUIDING CATHETER. WHEN THE BDC WAS REMOVED, ONLY THE PROXIMAL END CAME OUT AS THE DISTAL SHAFT HAD SEPARATED NEAR THE HYPOTUBE. THE DISTAL SHAFT WAS RETRIEVED WITH THE GUIDING CATHETER AS A SINGLE UNIT. A NEW SAME 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 Consequences Or Impact To Patient

  MAUDE report 9566271 ↗
• MalfunctionDec 18, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT IN THE 6FR GUIDING CATHETER, THE 3.25X12MM NC TREK BALLOON CATHETER MET RESISTANCE AND THE SHAFT SEPARATED. THE DEVICE WAS SIMPLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 9489612 ↗
• MalfunctionOct 18, 2019Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. EXCESSIVE FORCE WAS USED DURING INSERTION AND IT WAS NOTED THAT THE SHAFT KINKED IN MULTIPLE AREAS. ADDITIONALLY, THE PROXIMAL SHAFT SEPARATED AT THE SITE OF THE KINK OUTSIDE THE PATIENT ANATOMY. 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 9211384 ↗
• MalfunctionOct 10, 2019Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 3.25X12MM RX TREK BALLOON DILATATION CATHETER (BDC) FAILED TO INFLATE. 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. DEVICE ANALYSIS NOTED A TEAR AND LEAK IN THE OUTER MEMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176726 ↗
• MalfunctionSep 4, 2019Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PREPARATION, THE 3.25X12 NC TREK BALLOON DILATATION CATHETER (BDC), WAS BEING ADVANCED INTO AN UNSPECIFIED GUIDING CATHETER (GC) AND THE PROXIMAL SHAFT KINKED. DURING WITHDRAWAL, THE PROXIMAL SHAFT SEPARATED. THERE WAS NO PATIENT INVOLVEMENT AS BOTH THE BDC AND GC WERE OUTSIDE OF THE ANATOMY. THERE WAS NO RESISTANCE NOTED WITH THE GC. 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 Patient Involvement

  MAUDE report 8962511 ↗
• MalfunctionJun 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.25X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO PERFORM POST-DILATATION; HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THE BDC WAS REMOVED WITHOUT REPORTED ISSUE, AND A NEW SAME SIZE NC TREK BDC WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 8664928 ↗
• MalfunctionMay 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TREATING A MODERATELY TORTUOUS CIRCUMFLEX CORONARY ARTERY, HEAVILY CALCIFIED LESION. A 3.25X12MM NC TREK ADVANCED TO THE LESION WITHOUT REPORTED ISSUE. DURING THE FIRST INFLATION AT 18 ATM, THE NC TREK BALLOON BURST. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586741 ↗
• MalfunctionApr 30, 2019Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. AFTER THE NC TREK FAILED TO CROSS, DOCTOR TRIED TO ADVANCE WITH FORCE WHEN THE PROXIMAL SHAFT BROKE OUTSIDE THE PATIENT, IN HIS HAND. A NON-ABBOTT BALLOON WAS USED TO 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 8566685 ↗
• MalfunctionMar 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SHAFT OF A 3.25 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) SEPARATED. THE SEPARATION OCCURRED AT A POINT INSIDE OF AN UNSPECIFIED GUIDE CATHETER, THEREFORE THE PROXIMAL PART OF THE BDC WAS SIMPLY REMOVED WITH THE GUIDE CATHETER. 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 8384639 ↗
• MalfunctionOct 17, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED. UPON ADVANCEMENT OF A NC TREK RX 3.25X12 FOR POST-DILATATION, THE PROXIMAL SHAFT BROKE INSIDE THE GUIDING CATHETER BUT WAS SIMPLY WITHDRAWN. ANOTHER SAME SIZE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT OR REMOVAL. 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 7976029 ↗
• InjuryOct 12, 2018Difficult 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 PERFORMED TO TREAT AN 80% STENOSED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A KISSING TECHNIQUE ATTEMPT WAS MADE BY ADVANCING A 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) AND ANOTHER UNSPECIFIED BDC; HOWEVER, RESISTANCE ADVANCING THE 3.25X12MM NC TREK BDC WAS FELT WITH THE UNSPECIFIED BDC. THE BALLOONS BECAME STUCK AND RESISTANCE REMOVING THE NC TREK BDC WAS FELT WITH THE OTHER BDC. FORCE WAS APPLIED AND THE SHAFT SEPARATED. THE BDC DID NOT EXIT THE GUIDE CATHETER INTO THE CORONARY ANATOMY; THEREFORE, HEMOSTATS WERE USED TO REMOVE THE SEPARATED PORTION. 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 7962561 ↗
• MalfunctionOct 10, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.0X28MM XIENCE SIERRA WAS DEPLOYED AT THE LESION. POST-DILATATION WAS PERFORMED WITH A 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) AT 16 ATMOSPHERES (ATM). THE BALLOON WAS COMPLETELY DEFLATED. DURING REMOVAL, RESISTANCE WAS FELT WITH THE ANATOMY. WITH THE NC TREK STILL INSERTED, IT WAS ADVANCED AGAIN, INFLATED AT 16 ATM, DEFLATED COMPLETELY, AND THEN REMOVED FULLY FROM THE ANATOMY, WITH SLIGHT RESISTANCE NOTED STILL. TWO NON-ABBOTT BDC WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT IS FINE. 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 7953905 ↗