NC TREK 1012453-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 08717648152061), received between Aug 10, 2016 and Sep 29, 2026 — classified as 10 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (37 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-1129-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Fold; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935776 ↗
• InjuryOct 9, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23262742 ↗
• InjurySep 11, 2025Material Separation; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS REPORTED THAT THE NC TREK BALLOON CATHETER WAS USED SUCCESSFULLY; HOWEVER, DURING REMOVAL, THE DEVICE SEPARATED IN TWO PIECES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028676 ↗
• MalfunctionAug 6, 2025Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. FOLLOWING DILATATION WITH A 4.0 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC), THE BALLOON WAS NOTED TO BE DEFORMED AND COULD NOT BE WITHDRAWN THROUGH THE CATHETER. A SERIOUS INJURY WAS NOTED; HOWEVER, NO CLINICAL DELAY WAS REPORTED. ADDITIONAL INFORMATION REPORTED THAT THERE WAS MILD CALCIFICATION IN THE VESSEL, AND THE BALLOON FAILED TO FOLD DURING DEFLATION AFTER BEING PREPARED AND INFLATED 5 TIMES TO 12 ATMS WITH NO NOTED ISSUES USING 1:1 CONTRAST MIX. THE BDC ALONG WITH THE GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NON-ABBOTT DEVICE AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731162 ↗
• MalfunctionJul 7, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY. DURING ADVANCEMENT OF THE 4.00X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH ANATOMY HOWEVER, THE BDC SUCCESSFULLY CROSSED THE LESION. DURING REMOVAL, RESISTANCE WAS MET WITH ANATOMY AND ENHANCE NEGATIVE PRESSURE ASPIRATION WAS APPLIED, WHILE GENTLY ROTATING/PUSHING AND PULLING BACK THE NC TREK RX BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418351 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4X12MM NC TREK BALLOON DILATATION CATHETER (BDC), WHEN REMOVING THE PROTECTIVE SHEATH THE BALLOON SEPARATED. THE BDC WAS REPLACED WITH ANOTHER UNKNOWN BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: NO RESISTANCE WAS MET DURING REMOVAL OF THE PROTECTIVE SHEATH; NOR WAS FORCE APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785481 ↗
• MalfunctionAug 2, 2024Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER DID NOT FULLY DEFLATE AND WHEN ATTEMPTING TO REMOVE RESISTANCE WAS FELT RESISTANCE. A BIT OF EXTRA FORCE WAS USED TO REMOVE THE BDC; HOWEVER, THE PROXIMAL SHAFT SEPARATED. THE SEPARATED PORTION REMAINED IN CATHETER; THEREFORE, WAS REMOVED WITH THE CATHETER. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19894599 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). REPORTEDLY THE 4.00 X 12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY HOWEVER THE SHAFT SEPARATED. THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. ANOTHER NC TREK OF THE SAME SIZE WAS USED, AND THE PROCEDURE WAS 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 19689466 ↗
• MalfunctionJun 12, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH CALCIFICATION. FOR POST DILATATION, THE 4X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USES AND THE BALLOON WAS INFLATED TO 14 ATMOSPHERES (ATM); HOWEVER, THE BALLOON BECAME STUCK WITH THE PREVIOUSLY IMPLANTED STENT. NEGATIVE WAS HELD FOR 2 SECONDS AND THE BALLOON DEFLATED 5%. THE BDC HAD TO BE REMOVED WITH THE OTHER DEVICES BEING USED IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524261 ↗
• MalfunctionJun 12, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT MAIN. HE 4.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED TWICE TO 14 ATMOSPHERES. DURING DEFLATION CONTRAST WAS NOTED STILL IN THE BALLOON. DEFLATION WAS ATTEMPTED AGAIN AND THE BDC WAS REMOVED WITH RESISTANCE NOTED. IT WAS NOTED THE BALLOON WAS NOT COMPLETELY DEFLATED. AFTER STENTING POST DILATATION WAS PERFORMED WITH THE 4.0X12MM NC TREK HOWEVER WHEN DEFLATING THE BALLOON, CONTRAST WAS SEEN INSIDE BALLOON. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON AND RESISTANCE WAS MET DURING RETRACTION. THE BDC AND GUIDING CATHETER WERE REMOVED TOGETHER AS A UNIT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518831 ↗
• MalfunctionFeb 26, 2024Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE CARDIAC INFARCTION. THE PROCEDURE WAS TO TREAT A AN 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER STENT IMPLANTATION, THE 4X12MM NC TREK BALLOON DILATION CATHETER (BDC) WAS USED FOR POST DILATATION. THE BALLOON WAS INFLATED; HOWEVER, THE THE BALLOON DID NOT PROPERLY REFOLD PRIOR TO REMOVAL. THEREFORE, THE BDC HAD TO BE REMOVED WITH GUIDE CATHETER AS A SINGLE UNIT. 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 18782275 ↗
• MalfunctionJan 29, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT 12 ATMOSPHERES (ATMS) AND NEGATIVE WAS HELD FOR 5 SECONDS, HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED SO IT COULD NOT BE USED AGAIN. THE BDC WAS ATTEMPTED TO BE REMOVED PARTIALLY INFLATED BUT THE BALLOON BECAME TRAPPED IN THE GUIDE CATHETER. THE GUIDE CATHETER TOGETHER WITH THE BDC WAS PULLED OUT WITH EXCESSIVE FORCE. 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 18598819 ↗
• InjuryDec 21, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CORONARY ATHEROSCLEROTIC HEART DISEASE AND THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH 90% STENOSIS. A STENT WAS IMPLANTED, HOWEVER, STENOSIS WAS STILL OBSERVED IN THE STENT SO RE-DILATATION WAS PERFORMED USING THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) TO ELIMINATE THE STENT STENOSIS. THE BDC WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. AFTER THE BALLOON WAS INFLATED ONCE AT 12 ATMOSPHERES (ATMS) NEGATIVE HELD FOR 3 SECONDS, THE BDC COULD NOT BE RETRIEVED DURING REMOVAL. THE BALLOON COMPLETELY FAILED TO DEFLATE. THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND THE GUIDE WIRE. THE BALLOON HAD BEEN DILATED AND BLOCKED THE PROXIMAL SEGMENT OF THE RIGHT CORONARY ARTERY PUTTING THE ARTERY IN A STATE OF MYOCARDIAL ISCHEMIA. ADJUSTING THE INFLATOR AND GUIDE CATHETER STILL DID NOT RETRIEVE THE BALLOON. THE PATIENT THEN PRESENTED WITH A CHANGE IN HEART RHYTHM SO BRUTE FORCE WAS USED TO PULL THE ENTIRE BDC TOGETHER WITH THE GUIDING CATHETER AND GUIDE WIRE BACKWARDS AND PULLED THE BALLOON OUT OF THE OSTIUM OF THE RIGHT CORONARY ARTERY INFLATED, RESTORING RIGHT CORONA

  Patient problems: Arrhythmia; Ischemia; Obstruction/Occlusion

  MAUDE report 18376300 ↗
• MalfunctionDec 4, 2023Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. PRIOR TO USE THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT PREPPED (AIR ASPIRATED). THE BDC WAS USED IN THE PROCEDURE; HOWEVER, UNDER ANGIOGRAPHY THE BALLOON WAS NOTED TO ONLY PARTIALLY INFLATE. AFTER REMOVAL OF THE BDC, BLOOD LEAKAGE WAS NOTED AT THE JOINT OF THE BDC SHAFT. ANOTHER SAME SIZE NC TREK 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 18258935 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE TORTUOSITY. THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED BETWEEN 14 ATMOSPHERES TO 18 ATMOSPHERES TO PRE-DILATE THE LESION. AFTER DEFLATING THE BALLOON AN ATTEMPT WAS MADE TO REMOVE THE BDC, BUT IT WAS STUCK WITH THE GUIDE WIRE. THEREFORE, THE BDC WAS REMOVED WITH THE DEVICES BEING USED IN THE PROCEDURE (GUIDE WIRE, GUIDE CATHETER) AS A SINGLE UNIT. 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 18145558 ↗
• InjuryNov 2, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN DISTAL LEFT MAIN ARTERY. THE 4.0X12MM NC TREK BALLOON WAS NOT SOAKED IN SALINE PRIOR TO USE (PER INSTRUCTIONS FOR USE). THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE BALLOON WAS INFLATED ONE TIME, BUT WHEN ATTEMPTING TO DEFLATE THE BALLOON, IT FAILED TO DEFLATE. DURING THE ATTEMPT TO REMOVE THE BDC, THE SHAFT SEPARATED. THE PROXIMAL END OF THE BDC WAS EASILY REMOVED; HOWEVER, THE DISTAL SHAFT AND BALLOON HAD TO BE RETRIEVED WITH A LASSO. THE PROCEDURE WAS DELAYED 30 MINUTES DUE TO THE ISSUES WITH THE BDC. A NEW ACCESS SITE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057891 ↗
• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH 50% STENOSIS. THE 4.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED WITHOUT RESISTANCE, HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION OF 7 TO 8 ATMOSPHERES (ATMS) FOR 5 SECONDS EACH INFLATION. THERE WAS NO RESISTANCE DURING REMOVAL. THERE WAS NO RESISTANCE WHEN PROTECTIVE SHEATH WAS REMOVED. ANOTHER NON-ABBOTT DEVICE 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 18051305 ↗
• InjuryMay 9, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED STENT WAS IMPLANTED AND THE 4.0 X 12 MM NC TREK DILATATION CATHETER WAS ADVANCED FOR POST DILATATION OF THE IMPLANTED STENT. THE DILATATION CATHETER BALLOON WAS INFLATED AND DEFLATED WITHOUT ISSUE. DURING REMOVAL, RESISTANCE WAS NOTED AND THE PHYSICIAN GAVE A SMALL TUG ON THE DEVICE. ON FLUOROSCOPY, IT WAS NOTED THAT THE BALLOON REMAINED STILL IN THE GUIDE CATHETER. THE BALLOON SEPARATED FROM THE DILATATION CATHETER SHAFT. THE SEPARATED BALLOON WAS REMOVED FROM THE PATIENT ANATOMY VIA SNARE. NO PORTION OF THE NC TREK REMAINED IN THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897446 ↗
• MalfunctionJan 9, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 4X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE ANATOMY. RESISTANCE WAS MET DURING ADVANCEMENT AND REMOVAL; HOWEVER IT WAS REMOVE AS A SINGLE UNIT. A NON- ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE BUT ALSO FAIL TO CROSS THE LESION DUE ANATOMY, SO THE PROCEDURE WAS DISCONTINUED. 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 16123500 ↗
• MalfunctionDec 22, 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 DURING PREPARATION OF THE 4.0X12 NC TREK BALLOON DILATATION CATHETER (BDC), AFTER FLUSHING, THE SHEATH WAS ATTEMPTED TO BE REMOVED HOWEVER RESISTANCE WAS MET AND THE BALLOON SEPARATED AND CAME OFF WITH THE SHEATH. THE DEVICE WAS FLUSHED PER INSTRUCTIONS FOR USE (IFU) AND THE DEVICE WAS PREPARED PRIOR TO REMOVING THE PROTECTIVE SHEATH/STYLET REMOVAL. ANOTHER SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034499 ↗
• MalfunctionOct 25, 2022Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE 4X12MM NC TREK BALLOON DILATATION CATHETER (BDC), THE PROTECTIVE SHEATH [YELLOW CAP] WAS DIFFICULT TO REMOVE. SUBSEQUENTLY, THE BDC COULD NOT BE INSERTED ONTO THE GUIDE WIRE (GW). THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670075 ↗
• MalfunctionOct 14, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID RIGHT CORONARY ARTERY. POST STENT IMPLANTATION, A 4X12MM NC TREK WAS ADVANCED WITHOUT ISSUE TO PERFORM POST DILATATION. AFTER ONE INFLATION AT 16 ATMOSPHERES, THE BALLOON WAS UNABLE TO DEFLATE ENTIRELY (DEFLATED PARTIALLY ONLY). IT WAS ATTEMPTED TO BE PULLED OUT VIA THE GUIDE CATHETER BUT RESISTANCE WAS MET. THEREFORE, THE BALLOON AND GUIDE CATHETER WERE PULLED OUT TOGETHER AS A SINGLE UNIT. IT WAS CONFIRMED THAT NEGATIVE STAYED ON WHILE REMOVING THE DEVICE. 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 15611319 ↗
• MalfunctionOct 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND UPON THE INITIAL INFLATION, A SMALL LEAK IN THE BALLOON WAS OBSERVED. THE BDC WAS IMMEDIATELY REMOVED FROM THE ANATOMY AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY POST-DILATATE THE LESION. 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 15611290 ↗
• MalfunctionSep 7, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 4X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. THE BDC WAS REMOVED WITH RESISTANCE MET FROM THE ANATOMY AND NO OTHER DEVICE WAS ABLE TO CROSS TO THE TARGET LESION; THEREFORE, A ROTABLATION PROCEDURE WILL BE PLANNED FOR A LATER DATE. 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 15372768 ↗
• InjuryJul 29, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER IMPLANTING A NON-ABBOTT STENT, A 4X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. WHILE ATTEMPTING TO REMOVE THE BDC AND PULL IT BACK INTO THE GUIDE CATHETER (GC), THE BALLOON SEPARATED INTO THE AORTA. A SNARE WAS USED TO REMOVE THE BALLOON WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136367 ↗