NC TREK NEO™ 1400300-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648232503), received between Jun 6, 2023 and Sep 25, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Rupture; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899759 ↗
• MalfunctionSep 21, 2026Material Rupture; Difficult to Advance

  It was reported that the procedure was to treat the right coronary artery (RCA) with moderate calcification, mild tortuosity and 90% stenosis after stent implantation. The 3x8 mm NC Trek Neo was used for post-dilatation and there was resistance noted during advancement. The balloon ruptured during the first inflation at 10 atmospheres. A non-Abbott balloon was used to complete the procedure. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843107 ↗
• MalfunctionMar 24, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3 X 8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND RUPTURED. ANOTHER 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 24677581 ↗
• MalfunctionMar 24, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED AND A NEW NC TREK 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 24677256 ↗
• MalfunctionFeb 16, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATE CALCIFICATION, MODERATE TORTUOSITY DISTAL LEFT CIRCUMFLEX (DLCX) LESION WITH 90% STENOSIS. A 3.0X8.0 MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM), THE BALLOON RUPTURED. A NEW 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 24348630 ↗
• MalfunctionJan 2, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.0 X 8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), NEGATIVE PRESSURE COULD NOT BE PULLED [LEAK]. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 23942950 ↗
• MalfunctionDec 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE 3.00 X 8MM NC TREK NEO RX WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION WITH RESISTANCE BETWEEN THE BALLOON AND THE LESION. HOWEVER, THE NC TREK RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE SECOND INFLATION. THEREFORE, THE NC TREK WAS REMOVED AND ANOTHER 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 23826635 ↗
• MalfunctionDec 9, 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 HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE SECOND INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH A NON-ABBOTT BALLOON. 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 23759988 ↗
• MalfunctionDec 1, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. AN NC TREK NEO RX 3.0X8MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED BUT HAD DIFFICULTIES CROSSING THE LESION. ONCE CROSSED, DILATION WAS PERFORMED; HOWEVER, THE BDC RUPTURED AT 10 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH A NON-ABBOTT 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 23680448 ↗
• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY TORTUOUS, MID LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WITH 90% STENOSIS. A 3.00 X 8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION. DURING POST-DILATION, AFTER STENT IMPLANTATION, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH AN NON-ABBOTT 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 23599463 ↗
• MalfunctionNov 19, 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, HEAVILY TORTUOUS RIGHT CORONARY ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 3.00X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), RESISTANCE BETWEEN THE BALLOON AND LESION WERE NOTED. ONCE AT THE LESION, THE NC TREK NEO BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. THE NC TREK NEO BDC WAS REMOVED AND A NON-ABBOTT 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 23599329 ↗
• MalfunctionOct 24, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. THE 3.0X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH SLIGHT RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND UPON THE SECOND INFLATION TO 12 ATMOSPHERES, THE BALLOON RUPTURED. A NON-ABBOTT 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 23383910 ↗
• MalfunctionSep 10, 2025Material 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 LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND ADVANCED TO THE LESION THROUGH RESISTANCE, TO BE USED FOR VESSEL DILATATION. HOWEVER DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATM, AND THEREFORE THE BDC WAS REMOVED AND A NON-ABBOTT BDC WAS USED TO CONTINUE 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 23022011 ↗
• MalfunctionJun 10, 2025Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn; Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. FOR POST DILATATION, DURING ADVANCEMENT OF THE 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) ON A HT BMW UNIVERSAL II GUIDE WIRE (GW), RESISTANCE WAS NOTED AND THE GW BECAME SEPARATED IN 2 PIECES. RESISTANCE WAS NOTED BETWEEN THE GW AND BDC DURING REMOVAL; THEREFORE, THE SEPARATED PORTION OF THE GW WAS REMOVED WITH THE BDC AND THE OTHER PORTION OF THE GW WAS ABLE TO BE SIMPLY REMOVED. IT WAS NOTED THE GUIDE WIRE EXIT NOTCH, THE INNER AND THE OUTER MEMBER OF THE BDC WERE TORN. NO POST DILATATION WAS PERFORMED 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 22177645 ↗
• MalfunctionMay 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 3.0X08MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 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 22113789 ↗
• MalfunctionNov 21, 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 LEFT ANTERIOR DESCENDING ARTERY. A 3.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCE INTO THE ANATOMY WITH RESISTANCE NOTED. DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8 ATMOSPHERES. THE BDC WAS REMOVED AND ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. 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 20744708 ↗
• MalfunctionJul 25, 2024Material 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3X8MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON OF THE BDC WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS 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 19829312 ↗
• MalfunctionJul 23, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE OF THE ANATOMY WITHOUT ANY ISSUES. THE BDC WAS ADVANCED AND RESISTANCE WAS FELT WITH THE ANATOMY. DURING PRE-DILATATION, THE BALLOON RUPTURED DURING THE THIRD INFLATION TO 18 ATMOSPHERES DUE TO CALCIFICATION. THE PATIENT WAS TREATED WITH ROTABLATION AND STENT DEPLOYMENT. 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 19806696 ↗
• MalfunctionJul 10, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 3X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY, AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 17 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS 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 19713519 ↗
• MalfunctionJun 4, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE WITH THE ANATOMY NOTED. THE BALLOON WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED AT 12 ATMOSPHERES AFTER TWO INFLATIONS. A NON-ABBOTT 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 19460807 ↗
• MalfunctionMay 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, MILDLY TORTUOUS AND 60% STENOSED. THE NC TREK NEO WAS USED TO TREAT THE LESION. AFTER IT WAS DEFLATED, IT GOT STUCK WITH THE 7F CATHETER. TO COMPLETE THE PROCEDURE, ALL DEVICES WERE REMOVED WITH NO INTERVENTION REQUIRED. THERE WERE NO REPORTED 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 19253152 ↗
• MalfunctionMar 26, 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 HEAVILY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY. AFTER ROTABLATION WAS PERFORMED AND A 3.0X8MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED. DURING INFLATION THE FIRST INFLATION THE BDC RUPTURED AT 8 ATMOSPHERES. IT WAS NOTED THAT 3.0X8MM NC TREK NEO WAS NOT SOAKED PRIOR TO USE, GAUZE WAS SOAKED WITH SALINE AND WIPED THE DEVICE PRIOR TO USE. ANOTHER 3.0X10MM BALLOON TO PRE-DILATE AND A 3.0X12MM XIENCE SKYPOINT WAS SUCCESSFULLY IMPLANTED. A 3.0X12MM NC TREK NEO WAS USED FOR STANDARD POST DILATATION. 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 18983978 ↗
• MalfunctionMar 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR POST DILATION, THE 3X8MM NC TREK NEO BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED. HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NOT 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 18942241 ↗
• MalfunctionAug 21, 2023Material 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 CIRCUMFLEX (CX) ARTERY. THE 3.0X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE TO TREAT IN-STENT RESTENOSIS. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. REPORTEDLY, THE BALLOON HAD NOT BEEN SOAKED PRIOR TO USE. THE BDC WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 3.0X12MM NC TREK NEO BALLOON. 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 17589048 ↗
• MalfunctionJun 6, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 3.00X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND INFLATED ONE TIME TO 7 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. ANOTHER 3.00X8MM NC TREK NEO BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076120 ↗