NC TREK NEO™ 1400400-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08717648232701), received between Mar 30, 2023 and Sep 30, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (25 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 18, 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.

• MalfunctionSep 30, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949537 ↗
• MalfunctionJan 8, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PRE-DILATED WITH A 3.0MM BALLOON, FOLLOWED BY IVUS TO CONFIRM CALCIFICATION. AFTER ATHERECTOMY WAS PERFORMED, THE 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED AT 11 ATMOSPHERES (ATM). A 4.0X15MM XIENCE SKYPOINT STENT WAS DEPLOYED; HOWEVER, THE STENT WAS NOT WELL APPOSED TO THE VESSEL WALL DUE TO THE CALCIFICATION. AN ADDITIONAL 4.0X15MM XIENCE STENT WAS INFLATED TO 15 ATM WITHOUT ISSUES, COMPLETING 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 24003323 ↗
• MalfunctionDec 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 4.00 X 8 MM NC TREK NEO BALLOON DILATATION CATHETER, RESISTANCE WAS ENCOUNTERED DUE TO ANATOMY. ONCE AT THE LESION, THE NC TREK NEO BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. A NEW NC TREK BALLOON WAS USED TO 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 23926220 ↗
• MalfunctionNov 26, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER MET RESISTANCE WITH ANATOMY WHEN ADVANCING THE BALLOON TO THE TARGET SITE. DURING THE SECOND INFLATION THE BALLOON CATHETER RUPTURED 8 ATMOSPHERES. ANOTHER NC TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 23661096 ↗
• MalfunctionNov 6, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATION, THE 4X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED DUE TO RESISTANCE WITH THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PATIENT. ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490542 ↗
• MalfunctionOct 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. AFTER DEPLOYMENT OF A 3.5X12M MULTIMASTER NAGOMI SIROLIMUS-ELUTING STENT IN THE 6TH SEGMENT PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, POST-DILATION WAS ATTEMPTED USING A 4.00X8MM NC TREK BALLOON DILATATION CATHETER. AFTER 2 INFLATIONS AT 12 ATMOSPHERES, THE NC TREK BALLOON RUPTURED ON THE THIRD INFLATION AT 16 ATMOSPHERES. A 4.0X6MM HIRU BALLOON WAS USED FOR DILATION AND COMPLETION OF 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 23361319 ↗
• MalfunctionSep 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 4.0X8 MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED TWICE TO 8 ATMOSPHERES AND RUPTURED. A NEW NC TREK 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 23100745 ↗
• MalfunctionAug 14, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES, THE DEVICE WAS ADVANCED TO THE LESION, THROUGH RESISTANCE, AND ATTEMPTED TO BE INFLATED. HOWEVER DURING THE INITIAL INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE, THE BDC WAS REPLACED WITH A NC TREK BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809814 ↗
• MalfunctionJul 14, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 4.0X8MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE TARGET LESION, THROUGH RESISTANCE, TO BE USED FOR POST-DILATATION. HOWEVER DURING THE INITIAL INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 12ATMS. THEREFORE THE BDC WAS REMOVED AND A NEW UNKNOWN BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501482 ↗
• MalfunctionJul 10, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. 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 22467361 ↗
• MalfunctionApr 29, 2025Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A CIRCUMFLEX ARTERY THAT IS 70% STENOSED. A 4.00X8MM NC TREK NEO BALLOON WAS INFLATED ONCE TO 14 ATMOSPHERES AND AFTER MULTIPLE ATTEMPTS TO DEFLATE THE NC TREK NEO BALLOON, HOWEVER UNSUCCESSFUL, THE PARTIALLY DEFLATED NC TREK NEO BALLOON WAS SIMPLY WITHDRAWN. IT WAS NOTED THAT THE PATIENT EXPERIENCED PAIN DURING THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21928288 ↗
• MalfunctionApr 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). FOLLOWING THE DEPLOYMENT OF A 3.5X10MM NON-ABBOTT STENT, A 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED THROUGH RESISTANCE WITH A DEPLOYED STENT; HOWEVER, DURING THE INITIAL INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 6ATMS. THEREFORE, THE BDC WAS REMOVED AND A 4.0X10MM AND 4.0X20MM NON-ABBOTT DILATATION CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858425 ↗
• MalfunctionFeb 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF A 4.00X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) DUE TO ANATOMY. THE NC TREK NEO BDC WAS USED FOR PREDILATION WHEN THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. A NEW NC TREK BALLOON WAS USED TO 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 21359977 ↗
• MalfunctionFeb 3, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X8MM NC TREK BALLOON DILATATION CATHETER DID NOT INFLATE AND WAS OBSERVED TO BE LEAKING CONTRAST FROM THE SHAFT. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296864 ↗
• MalfunctionDec 9, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER A 4X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE IFU, IT WAS ADVANCED INTO THE ANATOMY THROUGH RESISTANCE; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATM. ANOTHER TREK BDC WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879370 ↗
• MalfunctionAug 22, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). REPORTEDLY DURING A 4.00X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), WAS USED FOR DILATATION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 18 ATMOSPHERES. ANOTHER NC TREK BDC 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 20030201 ↗
• MalfunctionJul 17, 2024Material 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 DISSECTION IN THE RIGHT CORONARY. A 4.08X8MM NC TREK NEO BALLOON DILATATION CATHETER ADVANCED AND INFLATED TO 32 ATMOSPHERES; HOWEVER, RUPTURED. A A 3.5X26MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO CROSS; HOWEVER, FAILED DUE TO ANATOMY. WHEN ATTEMPTING TO REMOVE THE DEVICE IT BECAME STUCK IN THE ANATOMY AND WAS NOTED TO BE DIFFICULT TO REMOVE. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763712 ↗
• MalfunctionMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR POST-DILATATION, THE 4X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 19355357 ↗
• MalfunctionMar 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A 50% STENOSED DE NOVO LESION IN THE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY WITH HEAVY CALCIFICATION. THE 4MM XIENCE STENT WAS IMPLANTED. THE 4X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND THE STENT WAS NOTED TO BE INDENTED. A NON-ABBOTT BALLOON WAS USED FOR FURTHER POST-DILATION OF THE STENT INDENTATION. 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 18904305 ↗
• MalfunctionFeb 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO RIGHT CORONARY ARTERY (RCA) LESION. A 4.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH NO RESISTANCE FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 8 ATMOSPHERES. A NEW NC TREK NEO BDC WAS USED TO CONTINUE 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 18641503 ↗
• MalfunctionJan 15, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.0X8MM NC TREK NEO 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 FROM THE PATIENT AND DIFFICULTY WAS ALSO NOTED DUE TO THE ANATOMY. 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 18515036 ↗
• InjuryNov 6, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THAT 3.0X28MM XIENCE STENT MENTIONED WAS TREATING THE LESION THAT WAS ALREADY THROMBUS AND WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080833 ↗
• MalfunctionNov 3, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 4.0X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED AND RESISTANCE WAS NOTED WITH THE ANATOMY. 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 18067859 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A STENT WAS DEPLOYED AND THE NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 14 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 17366204 ↗
• MalfunctionJul 13, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. AFTER CUTTING, THE 4.0X8.XMM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE. THE FIRST INFLATION WAS FOR 10 SECONDS AT 16 ATMOSPHERES AND THE SECOND INFLATION WAS FOR 10 SECONDS; HOWEVER, IN THIS INFLATION A RUPTURE OCCURRED AT 18 ATMOSPHERES. THERE WAS RESISTANCE DURING ADVANCEMENT DUE TO ANATOMY. 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 17321532 ↗