NC TREK 1012447-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 08717648151767), received between Aug 19, 2016 and Feb 27, 2025 — classified as 3 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (33 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2025Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER A 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, IT WAS ADVANCED TO THE LESION AND WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION. HOWEVER, THE BDC WAS NOTED TO FAIL TO INFLATE, AND AFTER THE BDC WAS REMOVED A BREAK WITHIN THE INNER MEMBER OF THE SHAFT WAS NOTED. THE BDC WAS REMOVED AND REPLACED WITH ANOTHER ABBOTT BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. SUBSEQUENT TO THE INITIALLY REPORTED INFORMATION THE DEVICE WAS RECEIVED AND THE ANALYSIS REVEALED A SEPARATION OF THE HYPOTUBE AT 1MM DISTALLY FROM THE DISTAL END OF SINGLE ARM. BOTH PROXIMAL AND DISTAL SEGMENTS WERE RETURNED. THE ACCOUNT COULD NOT CONFIRM NOR DENY THE NOTED DAMAGES FOUND IN THE PRODUCT RETURN, DUE TO THE LACK OF RECOLLECTION OF THE DETAILS ON THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21483488 ↗
• MalfunctionNov 27, 2023Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT IS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT CIRCUMFLEX (LCX). WHEN THE PROTECTIVE SHEATH OF THE 2.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED DIFFICULTY WAS NOTED. THE BDC WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON FAILED TO INFLATE. THEREFORE, THE BDC WAS REMOVE FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 18213090 ↗
• MalfunctionAug 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 75% STENOSIS. THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND WAS INFLATED TO 12 ATMOSPHERES (ATM), 14 ATM AND 18 ATM AND RUPTURED AT 18 ATM. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623311 ↗
• MalfunctionAug 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC), THE TIP OF THE DEVICE SEPARATED. A NEW NC TREK WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558743 ↗
• MalfunctionJul 25, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 95% STENOSIS. DURING THE PROCEDURE, THE SHAFT OF THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND SEPARATED INTO TWO PIECES AT THE PROXIMAL PORTION. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN AND WAS DISCARDED AND A NEW BALLOON WAS USED TO COMPLETE 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 17389173 ↗
• InjuryJun 28, 2023Difficult to Remove; Material Split, Cut or Torn; Failure to Deflate; Difficult to Remove; Material Split, Cut or Torn; Failure to Deflate

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: NEGATIVE WAS HELD FOR AT LEAST 20 SECONDS WITH RECURRENT PULLS NEGATIVE. THE INFLATED BALLOON WAS PULLED INTO A 7F SHEATH WITH RESISTANCE, AT WHICH POINT THE DISTAL TIP OF THE DEVICE WAS TORN, AND THE MARKER BANDS WERE NOTICED IN THE GUIDE TIP, HOWEVER THE DEVICE WAS REMOVE FROM THE ANATOMY WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219402 ↗
• MalfunctionJun 27, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED VESSEL. THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) DID NOT DEFLATE AND HAD TO BE REMOVED WHILE STILL INFLATED. 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 17209565 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL ARTERY. THERE WERE 16 BALLOONS USED IN THE PROCEDURE FOR DILATATION. HOWEVER, 8 OUT OF THE 16 BALLOONS USED HAD ISSUES. TWO NC TREK BALLOONS, 3.0X8MM AND 4.0X8MM, LOST PROFILE. FOUR NC TREK BALLOONS, 2.0X20MM, 2.5X15MM, 3.0X15MM AND 3.0X20MM, HAD BALLOON RUPTURES. ANOTHER 2 TREK BALLOONS, 2.25X12MM AND 2.5X15MM, ALSO HAD BALLOON RUPTURES. 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 17127670 ↗
• MalfunctionJun 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BALLOON WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 17042145 ↗
• MalfunctionMay 23, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 12 ATMOSPHERES. NEGATIVE PRESSURE WAS HELD FOR 3 SECONDS AND THE BALLOON WAS FULLY DEFLATED UPON REMOVAL; HOWEVER, THERE WAS RESISTANCE WITH THE GUIDING CATHETER DURING REMOVAL AND FORCE WAS APPLIED. THE PROXIMAL SHAFT SEPARATED AND THE DISTAL PORTION WAS SIMPLY WITHDRAWN. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985413 ↗
• InjuryMay 10, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND USED FOR DILATATION WITHOUT ISSUE. UPON ATTEMPTED REMOVAL OF THE DEVICE, THE BALLOON WAS BEING PULLED BACK INTO THE CATHETER, BUT MET RESISTANCE WITH THE CALCIFICATION IN THE RCA. THE PHYSICIAN PULLED THE BDC TO PULL IT BACK INTO THE CATHETER, RESISTANCE WAS THEN MET WITH THE GUIDE CATHETER, AND THE BALLOON SEPARATED FROM THE HYPOTUBE. THE SEPARATED BALLOON WAS REMOVED BY ENDARTERECTOMY, AND THE PROCEDURE WAS COMPLETED VIA CORONARY ARTERY BYPASS SURGERY (CABG). THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903935 ↗
• MalfunctionApr 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 16 ATMOSPHERES (ATM) 3 TIMES; HOWEVER, THE BALLOON RUPTURED BELOW RATED BURST PRESSURE (RBP). THEREFORE, 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 CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832013 ↗
• MalfunctionApr 24, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. FOR POST DILATATION THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE BDC WAS REMOVED AND DIFFICULTY WAS ALSO NOTED DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795798 ↗
• MalfunctionMar 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) THE HUB SEPARATED FROM 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 16645303 ↗
• MalfunctionMar 8, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY WITH 90% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN PROTECTIVE SHEATH WAS REMOVED. THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. THERE WAS NO RESISTANCE UPON REMOVAL. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506459 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. DURING ADVANCEMENT, THE HUB OF THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) SEPARATED INTO TWO PIECES WITHOUT ANY NOTED RESISTANCE. THE DEVICE WAS REMOVED WITHOUT ISSUE AND WITH NOTHING REMAINING IN THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A 2.5X15MM NC TREK DEVICE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392879 ↗
• MalfunctionDec 6, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL CORONARY ARTERY. AN NC TREK BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED INTO A GUIDE CATHETER (GC), WHEN STRONG RESISTANCE WAS MET BETWEEN THE BDC AND THE GC, CAUSING THE SHAFT OF THE BDC TO BECOME SEPARATED INSIDE OF THE GUIDE CATHETER. THE BDC AND ALL SEPARATED PIECES WERE SIMPLY REMOVED WITHOUT ISSUE, NO SNARE WAS REQUIRED, AND NO MATERIAL WAS LEFT IN THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926353 ↗
• MalfunctionOct 25, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT PREPPED OUTSIDE THE ANATOMY (AIR ASPIRATION) PRIOR TO USE. THE BDC WAS INFLATED ONCE TO NOMINAL PRESSURE AND DYE WAS NOTED ON FLUOROSCOPY. ANOTHER 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 15668160 ↗
• MalfunctionSep 20, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BIFURCATION OF THE DISTAL CIRCUMFLEX AND MARGINAL BRANCH ARTERIES. THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE. FOLLOWING POST DILATATION IN THE DISTAL CIRCUMFLEX THE BDC WAS ATTEMPTED TO BE ADVANCED TO PERFORM THE FINAL KISSING BALLOON TECHNIQUE; HOWEVER THE BDC BECAME STUCK WITH HT BMW UNIVERSAL II GUIDEWIRE (GW). THE BDC AND THE GW WERE REMOVED TOGETHER AS A SINGLE UNIT FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN PROCEDURE. ANOTHER BDC AND GW WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459722 ↗
• MalfunctionJul 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED DE NOVO MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. A 2.5X15MM NC TREK BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 3 ATMOSPHERES FOR 5 SECONDS AND RUPTURED. ANOTHER NC TREK WAS USED AND A XIENCE STENT 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 15089031 ↗
• MalfunctionJun 29, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. AN UNSPECIFIED XIENCE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED; HOWEVER, AFTER PERFORMING INTRAVASCULAR ULTRASOUND (IVUS), IT WAS DECIDED TO PERFORM STANDARD POST-DILATATION. THE 2.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AGAINST RESISTANCE FROM THE ANATOMY TO THE STENT FOR POST DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 7 ATMOSPHERES (ATM) AFTER 5 SECONDS. THE BDC WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14864062 ↗
• MalfunctionJun 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. WHILE ADVANCING THE 2.5X15MM NC TREK INTO THE SHEATH OVER THE GUIDE WIRE, THE PROXIMAL SHAFT SNAPPED IN HALF. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WERE NO KINKS OR OTHER ISSUES NOTED PRIOR TO INSERTING THE BALLOON AND NO ABNORMAL FORCE WAS APPLIED WHEN INSERTING THE BALLOON. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER TREK WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES AND THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750253 ↗
• InjuryJun 1, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 2.5X18MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INSERTED AND ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. AFTER INFLATING AND FULLY DEFLATING THE BALLOON, THE BDC WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE BDC MET RESISTANCE WITH ANATOMY. ADDITIONAL FORCE WAS APPLIED TO THE DEVICE AND ONCE REMOVED IT WAS OBSERVED THAT A PORTION OF THE BALLOON HAD DETACHED. THE SEPARATED PORTION WAS REMOVED VIA SNARE. TWO UNSPECIFIED STENTS WERE IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565145 ↗
• MalfunctionMay 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE NC TREK BALLOON, THE SHAFT BROKE IN TWO PIECES DURING HANDLING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DAMAGE NOTED TO THE HOOP COIL OR CHIPBOARD BOX. THERE WAS NO RESISTANCE WHEN REMOVING THE DEVICE FROM THE HOOP COIL. ANOTHER NC TREK 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 14431957 ↗
• MalfunctionMay 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT CIRCUMFLEX CORONARY ARTERY. THE 2.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED WHEN INFLATED TWICE TO 14 ATMOSPHERES (ATM). THERE WAS NO RESISTANCE DURING ADVANCEMENT AND THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. A NON-ABBOTT BDC WAS USED TO COMPLETE 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 14337625 ↗