NC TREK 1012453-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08717648152054), received between Sep 12, 2016 and May 12, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (17 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 29, 2020Terminated

   Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

   Z-1128-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN ARTERY. FOR POST-DILATATION, THE 4X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED FOUR TIMES TO 18-22 ATMOSPHERES (ATM); HOWEVER, THE BDC WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE BDC WAS NOT ABLE TO BE RETRACTED INTO THE GUIDE CATHETER (GC), AND THE DISTAL PORTION OF THE BALLOON WAS NOTED TO HAVE FAILED TO REFOLD. THE BDC WAS ABLE TO BE FORCIBLY PULLED OUT OF THE PATIENT. OTHER UNSPECIFIED DEVICES WERE USED TO CONTINUE 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 25153070 ↗
• MalfunctionJul 16, 2025Difficult to Remove; Material Separation; Failure to Deflate; Difficult to Remove; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOR POST DILATATION, THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, AFTER MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON, THE BALLOON FAILED TO DEFLATE. THE BDC WAS ATTEMPTED TO REMOVED; HOWEVER, THE BDC COULD NOT BE RETRACTED IN THE GUIDE CATHETER (GC) AND SHAFT OF THE BDC BECAME FRACTURED [SEPARATED]. THEREFORE, THE BDC AND GC WERE REMOVED AS A SINGLE UNIT. OUTSIDE THE PATIENT ANATOMY THE BDC WAS ABLE TO BE REMOVED FROM THE GC. THE GC WAS REINSERTED TO CONTINUE 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 22524284 ↗
• MalfunctionApr 17, 2025Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  THE NMPA REPORT NUMBER IS (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4 X 8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED AT THE LESION AND INFLATED 1-2 TIMES TO 16 ATMS AND COMPLETELY DEFLATED; HOWEVER, DURING THE WITHDRAWAL RESISTANCE WAS FELT. AFTER THE DEVICE WAS REMOVED WITH FORCE, THE BALLOON WAS NOTED TO BE BROKEN [RUPTURED]. THEREFORE, A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859104 ↗
• MalfunctionOct 3, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY WITH MILD CALCIFICATION AND 70% STENOSIS. A NON-ABBOTT GUIDE CATHETER EXTENSION WAS ADVANCED AND PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED NON-COMPLIANT (NC) BALLOON. A XIENCE SIERRA STENT WAS IMPLANTED. THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR POST DILATATION AND WAS FLUSHED; HOWEVER, THE PROTECTIVE SHEATH WAS NOT REMOVED PRIOR TO FLUSHING. RESISTANCE WAS FELT WHEN REMOVING THE PROTECTIVE SHEATH, AND IT WAS UNABLE TO BE REMOVED. A 4.0X12 NC TREK BDC WAS THEN USED TO CONTINUE THE PROCEDURE, AS A SECOND 4.0X8MM NC TREK WAS NOT AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363743 ↗
• MalfunctionApr 26, 2024

  PATIENT WAS BROUGHT TO CARDIAC CATH LAB (CCL) FROM EMERGENCY DEPARTMENT (ED) IN AN EMERGENT SETTING. VERBAL CONSENT WAS OBTAINED. PATIENT EXPLAINED OF ALL RISKS AND AGREED TO PROCEED. PER DOCTOR'S NOTES: POST-INTERVENTION WITH DRUG ELUTING STENT (DES), A NON-COMPLIANT (NC) BALLOON WAS INSERTED. DURING INFLATION THIS BALLOON RUPTURED AND ENDED UP MIGRATING INTO THE PROXIMAL-MID LEFT ANTERIOR DESCENDING ARTERY (LAD), AND REQUIRED RETRIEVAL VIA GUIDELINER AND BALLOON WITH PULLBACK, WHICH WAS PERFORMED SUCCESSFULLY BY TRAPPING THIS RUPTURED BALLOON. PER REGISTERED NURSE (RN) REPORT: PRODUCT: ABBOTT NON-COMPLIANT CORONARY DILATION CATHETER, SIZE 4.0 X 8.0 MM. BALLOON WAS BEING INFLATED IN CORONARY ARTERY AND RUPTURED DURING INFLATION. BALLOON WAS WELL BELOW THE RATE OF BURST PRESSURE AND DEVICE SNAPPED OFF AT THE SHAFT AT THE MIDPOINT OF THE BALLOON. APPROXIMATELY 7MM OF THE DISTAL SHAFT AND THE DISTAL HALF OF THE BALLOON BROKE OFF AND WAS STUCK IN THE LEFT ANTERIOR DESCENDING ARTERY. PIECES WERE SAFELY RETRIEVED, AND THE CASE FINISHED WITHOUT PATIENT HARM. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, NC TREK (PER SITE REPORTER). CCL MANAGER CALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191634 ↗
• InjuryJan 8, 2024Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 4.0X8 MM TREK BALLOON DILATATION CATHETER (BDC) SEPARATED AND THE DISTAL PORTION REMAINED IN THE ANATOMY. A SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION. THERE WERE NO ADVERSE PATIENT SEQUELA. SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THE VESSEL WAS SEVERELY CALCIFIED AND MODERATELY TORTUOUS. THE BALLOON WAS INFLATED ONCE AND RUPTURED AT 5 ATMOSPHERES AND THEN DURING REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY AND FORCE WAS APPLIED. SEVEN MM OF THE DISTAL SHAFT AND THE DISTAL HALF OF THE BALLOON SEPARATED AND BECAME STUCK AT THE LAD. NO SNARING WAS REQUIRED, EVERYTHING WAS PULLED OUT TOGETHER AS A UNIT. A NEW ABBOTT NC 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465601 ↗
• MalfunctionJan 2, 2024Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. PRIOR TO THE PROCEDURE, WHEN ATTEMPTING TO REMOVE THE PROTECTIVE SHEATH FROM THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS NOTED. A SECOND ATTEMPT WAS MADE TO REMOVE THE SHEATH, BUT IT WAS STUCK SO TIGHTLY THAT FORCE WAS USED, AND THE BALLOON BECAME STRETCHED. THE BDC WAS NOT USED IN THE PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER NC TREK BDC WAS USED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432237 ↗
• MalfunctionSep 22, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS. THE NC TREK RX BALLOON WAS USED AND AFTER DEFLATION, THE DILATATION CATHETER GOT STUCK WITH THE GUIDE WIRE DURING REMOVAL. THE NC TREK AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. 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 17799159 ↗
• InjurySep 5, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION OF A STENT. AFTER THE 1ST INFLATION AT 18 ATMOSPHERES (ATM), THE BALLOON DEFLATED NORMALLY. AFTER 2ND INFLATION AT 12 ATM THE BALLOON ONLY PARTIALLY DEFLATED, AND AFTER RE-INFLATION IN THE AORTA, THE BALLOON COMPLETELY FAILED TO DEFLATE. THEREFORE, A GUIDE WIRE WAS USED TO POP (DEFLATE) THE BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684891 ↗
• MalfunctionAug 28, 2023Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method; Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION. AFTER AN UNSPECIFIED STENT WAS PLACED. THE 4.0X8.0MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED PRIOR TO USE AND WAS INTRODUCED TO POST DILATE THE LESION. UNDER FLUOROSCOPY A LEAK WAS NOTED AT THE DISTAL TIP OF THE BALLOON WHEN WAS INFLATED ONCE TO 12 ATMOSPHERES AND DID NOT HOLD PRESSURE. THEREFORE, BY USING AN INDEFLATOR CONTINUOUSLY TO INFLATE THE BALLOON, IT WAS POSSIBLE TO POST DILATE THE LESION TO 4 MM AND COMPLETE THE PROCEDURE. THE DEVICE WAS REMOVED AS A SINGLE UNIT AND PRESSURIZED TO CONFIRM THE BALLOON LEAK. 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 17633566 ↗
• MalfunctionMar 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) SHAFT SEPARATED DURING THE PROCEDURE. HOWEVER, IT WAS NOTED THAT SEPARATED SHAFT REMAINED ON THE GUIDE WIRE THEREFORE, EVERYTHING WAS REMOVED AS ONE UNIT. 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 16639326 ↗
• MalfunctionJan 13, 2023Deflation Problem; Product Quality Problem; Difficult to Remove; Deflation Problem; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER POST DILATATION, THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) DID NOT DEFLATE SUFFICIENTLY AND WAS DIFFICULT TO FULLY PULL BACK INTO THE GUIDE CATHETER (GC). THE BDC WAS EVENTUALLY PULLED BACK INTO THE GC WITH THE BALLOON PROTRUDING OUT OF THE DISTAL END OUT OF THE RADIAL SHEATH AND WAS REMOVED 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 16161968 ↗
• MalfunctionJan 3, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE 4.00X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). DURING THE LEFT MAIN CORONARY ARTERY CORONARY INTERVENTION AFTER IMPLANTATION OF A 4.00X12MM NON-ABBOTT STENT, THE BDC WAS ADVANCED WITHOUT ISSUE; HOWEVER, AFTER BALLOON INFLATION TO 22 ATMOSPHERES (ATM), THE BALLOON FAILED TO DEFLATE. IT IS UNKNOWN HOW LONG NEGATIVE PRESSURE WAS HELD. THE FULLY INFLATED BALLOON WAS REMOVED WITH THE GUIDEWIRE AND GUIDE CATHETER, AS A SINGLE UNIT. 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 16091342 ↗
• MalfunctionDec 21, 2022Failure to Fold; Difficult to Remove; Material Rupture; Difficult to Advance; Failure to Fold; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 75% STENOSIS. AFTER PRE-DILATATE THE LESION TWICE WITH A 4.00 X 8MM NC TREK A RUPTURE OCCURRED IN THE SECOND INFLATION AT 12 ATMOSPHERES AND REMOVED INDEPENDENTLY. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE DILATATION AND A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. RESISTANCES WITH THE LESION WAS MET DURING THE ADVANCEMENT AND REMOVAL. THE BALLOON WAS NOT FOLDED. 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 16024082 ↗
• MalfunctionNov 4, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED 3 TIMES TO 12, 14 AND 14 ATMOSPHERES (ATM). THE BALLOON FULLY DEFLATED AFTER THE LAST INFLATION; HOWEVER, IT WAS DIFFICULT TO PULL BACK INTO THE 6F GUIDE CATHETER AFTER POST-DILATATION OF THE STENT. 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 15723710 ↗
• MalfunctionAug 29, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID-RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS AND 90% STENOSED. THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER AFTER THE FIRST INFLATION, A LEAK OF THE CONTRAST AGENT WAS NOTED FROM THE BALLOON. AFTER REMOVAL, A PINHOLE RUPTURE WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 4.0X12MM NC TREK BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316540 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 95% RE-STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 4X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR PRE-DILATATION, INFLATED ONCE TO 15 ATMOSPHERES (ATM) AND HELD FOR 20 SECONDS WHEN THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108841 ↗
• MalfunctionJul 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS A CORONARY INTERVENTION. THE 4.0X8 MM NC TREK BALLOON WAS NOTED TO BE LOOSE ON THE DILATATION CATHETER. IT WAS MOVING ON THE CATHETER. 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 15095084 ↗
• MalfunctionFeb 24, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND NON-TORTUOUS. A 3.0X33MM SKYPOINT STENT WAS SUCCESSFULLY IMPLANTED AND WAS POST-DILATED WITH TWO NC TREK BALLOON DILATATION CATHETERS (BDC), A 3.5X15MM, AND A 4.0X8MM. THE 4.0X8MM WAS INFLATED ONCE TO 16 ATMOSPHERES (ATM) FOR 20 SECONDS. DURING REMOVAL OF THE 4.0X8MM NC TREK BDC, IT COULD NOT BE FULLY RETRACTED INTO THE GUIDE CATHETER, SO THE DEVICES WERE REMOVED AS A SINGLE UNIT. AFTER THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE BALLOON WAS STILL PARTIALLY INFLATED. THERE WAS NO REPORTED 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 13592786 ↗
• MalfunctionSep 20, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN A HEAVILY TORTUOUS CORONARY ARTERY. THE NC TREK DEVICE DID NOT CROSS DUE TO THE PATIENT ANATOMY AND THERE WAS RESISTANCE MET WITH THE LESION DURING REMOVAL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS TREATED WITH A NON-ABBOTT DEVICE TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12503062 ↗
• MalfunctionAug 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 4X8MM NC TREK BALLOON, IT WAS NOTED THAT THERE WERE RETURNING EXCESS AIR BUBBLES. THE BALLOON KEPT PULLING AIR, THUS A LEAK WAS SUSPECTED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED MDR, DEVICE ANALYSIS NOTED A HYPOTUBE SEPARATION. THE ACCOUNT CONFIRMED THIS WAS NOT NOTED DURING PREPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388335 ↗
• MalfunctionAug 19, 2021Difficult 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 90% STENOSED, HEAVILY CALCIFIED, MILDLY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. RESISTANCE WAS NOTED WITH THE LESION DURING ADVANCEMENT AND THE 4.00X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO 12 ATMOSPHERES (ATM) BUT RUPTURED. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. A CUTTING 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 12343092 ↗
• MalfunctionJul 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. A 4.0X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER FOLLOWED BY INTRAVASCULAR ULTRASOUND (IVUS). ADDITIONAL DILATATION WAS BEING PERFORMED WITH THE 4.0X8MM NC TREK RX BDC. THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATM) THE FIRST TIME AND 16 ATM THE SECOND TIME; HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 18 ATM. IVUS WAS PERFORMED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12206641 ↗
• MalfunctionJun 30, 2021Difficult 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 THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE LEFT MAIN ARTERY. FOLLOWING PRE-DILATATION WITH A 3.0X15MM TREK BALLOON DILATATION CATHETER (BDC), A 3.5X28MM XIENCE SIERRA STENT WAS DEPLOYED. A 4.0X8MM NC TREK RX BDC WAS BEING ADVANCED THROUGH THE GUIDING CATHETER FOR POST-DILATATION; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. THE BDC WAS CAREFULLY REMOVED, BUT RESISTANCE WITH THE GUIDE CATHETER WAS FELT AND IT WAS NOTED THAT THE PROXIMAL SHAFT WAS KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY POST-DILATING WITH A 3.75X15MM NC TREK BDC. 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 12093979 ↗
• MalfunctionMar 12, 2021Inflation Problem; Material Rupture; Difficult to Advance; Inflation Problem; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED RIGHT CORONARY ARTERY. DURING ADVANCEMENT A 4.0X8MM NC TREK BALLOON DILATATION CATHETER MET RESISTANCE WITH ANATOMY. INFLATION WAS ATTEMPTED ONCE TO 12 ATMOSPHERES; HOWEVER, THE BALLOON WAS NOTED TO BE LOSING PRESSURE AND FAILED TO INFLATE. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475110 ↗