MINI TREK™ 1012270-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 08717648138157), received between Sep 29, 2016 and Sep 24, 2026 — classified as 10 injuries, 213 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (170 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 223 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Rupture; Difficult to Advance

  It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous lesion in the left anterior descending artery with a 2.00x15mm MINI TREK RX balloon dilatation catheter (BDC). Reportedly, resistance was encountered at the lesion site when advancing the balloon to the target lesion. The balloon ruptured at 6 atmospheres during the first inflation. The BDC was removed from the patient. The procedure was continued using another TREK balloon. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884994 ↗
• MalfunctionJun 2, 2026Material 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 90% STENOSIS. THE 2.0X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. ANOTHER TREK 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 25363511 ↗
• MalfunctionMay 7, 2026Material 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 99% STENOSIS. THE 2.0X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATM AND RUPTURED. ANOTHER TREK 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 25113767 ↗
• MalfunctionMay 6, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT MAIN CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, A 2X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 6 ATMOSPHERES, (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, AND ANOTHER TREK BDC 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 25104881 ↗
• MalfunctionApr 16, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 2.00X15MM MINI TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET WITH THE LESION. ONCE AT THE LESION, THE MINI TREK BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE MINI TREK RX BDC WAS REMOVED, AND A NEW 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 24899618 ↗
• MalfunctionApr 3, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.0X15MM RX MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER 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 24778793 ↗
• MalfunctionMar 23, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 2.00 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WITH THE LESION WAS ENCOUNTERED. ONCE AT THE LESION FOR PRE-DILATATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE MINI TREK BDC WAS REMOVED, AND A NEW TREK BDC 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 24665398 ↗
• MalfunctionMar 18, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, AND 99% STENOSED LEFT ANTERIOR DESCENDING ARTERY. A TREK RX 2.00 X 15 MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT HAD DIFFICULTIES CROSSING THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 6ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED. 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 24635786 ↗
• MalfunctionMar 17, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM) DURING THE INITIAL INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK 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 24619853 ↗
• MalfunctionMar 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.00X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WAS ENCOUNTERED AT THE LESION. DURING PRE-DILATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES ON THE INITIAL INFLATION. THE MINI TREK WAS REMOVED AND A NEW UNSPECIFIED TREK BDC 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 24571960 ↗
• MalfunctionMar 10, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 2.0X15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WITH THE ANATOMY WAS NOTED. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED AND 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 24561240 ↗
• MalfunctionMar 5, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 2.00 X 15 MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS ENCOUNTERED AT THE LESION SITE. DURING THE FIRST INFLATION, THE MINI TREK BDC RUPTURED AT 6 ATMOSPHERES. THE MINI TREK BDC WAS REMOVED, AND A NEW 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 24514974 ↗
• MalfunctionFeb 25, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN AN UNSPECIFIED ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. FOR PRE-DILATATION, THE 2X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY; HOWEVER, THE BDC WAS ULTIMATELY ABLE TO CROSS THE LESION. AFTER PRE-DILATATION, THE BDC WAS WITHDRAWN FOR FURTHER IMAGING. THE BDC WAS RE-ADVANCED FOR FURTHER DILATATION, BUT THE BDC WAS NOT ABLE TO PASS SMOOTHLY THROUGH THE GUIDE CATHETER. THEN DURING REMOVAL OF THE BDC, RESISTANCE WAS ALSO NOTED WITH THE GUIDE CATHETER AND THE SHAFT SEPARATED. THE BDC WAS ABLE TO BE REMOVED FROM THE PATIENT BY SLIGHTLY WITHDRAWING THE GUIDE WIRE WHICH THE SEPARATED PORTION BECAME VISIBLE AND WAS ABLE TO BE WITHDRAWN. THE PROCEDURE WAS CONTINUED WITH A 2.5X12 TREK BDC FOLLOWED BY STENT IMPLANTATION. 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 24448502 ↗
• MalfunctionFeb 23, 2026Material 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. FOR PRE-DILATATION, THE 2X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER TREK BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424732 ↗
• MalfunctionFeb 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. ANOTHER TREK BALLOON WAS USED TO CONTINUE 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 24390902 ↗
• MalfunctionFeb 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00 X 15MM MINI TREK RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE MIN TREK RX BDC RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVED AND A NEW TREK BDC 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 24315468 ↗
• MalfunctionFeb 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00X15MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION FOR PRE-DILATION, THE MINI TREK BDC RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. A NEW 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 24315465 ↗
• MalfunctionFeb 10, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 12 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 24308507 ↗
• MalfunctionFeb 4, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. PRIOR TO USE, THE 2.00X15MM MINI TREK RX BALLOON DILATATION CATHETER WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. RESISTANCE WAS MET DUE TO ANATOMY AND ONCE AT THE LESION FOR PREDILATATION, THE MINI TREK BALLOON RUPTURED AT 14 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 2.00X15MM TREK 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 24262600 ↗
• MalfunctionFeb 3, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00X15MM MINI TREK BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING THE INITIAL INFLATION. THE MINI TREK BDC WAS REMOVED, AND ANOTHER TREK BDC 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 24251434 ↗
• MalfunctionJan 22, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, AND 90% STENOSED LEFT ANTERIOR DESCENDING ARTERY. A TREK 2.00X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT HAD DIFFICULTIES CROSSING THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. HOWEVER, THE BDC RUPTURED AT 6ATM. THEREFORE, THE BDC WAS REMOVED WITHOUT FURTHER ISSUES AND REPLACED WITH ANOTHER 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 24151706 ↗
• MalfunctionJan 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, AND 75% STENOSED LEFT ANTERIOR DESCENDING ARTERY. A TREK 2.0 X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. THE FIRST INFLATION AT 8ATM WAS PERFORMED WITHOUT ISSUE; HOWEVER, DURING THE SECOND INFLATION AT 12ATM, THE BALLOON RUPTURED. 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 24109300 ↗
• MalfunctionJan 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, AND 90% STENOSED LEFT CIRCUMFLEX ARTERY. A TREK 2.0 X15MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED AND ADVANCED BUT WAS DIFFICULT TO CROSS THE LESION. ONCE CROSSED, DILATION WAS PERFORMED. THE FIRST INFLATION AT 8ATM WAS PERFORMED WITHOUT ISSUE; HOWEVER, DURING THE SECOND INFLATION AT 10ATM, THE BALLOON RUPTURED. 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 24109183 ↗
• MalfunctionJan 13, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS CONTINUED WITH ANOTHER TREK 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 24060178 ↗
• MalfunctionDec 23, 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 CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.00X15MM MINI TREK RX BALLOON DILATATION CATHETER, RESISTANCE WAS NOTED DUE TO ANATOMY. ONCE AT THE LESION, THE MINI TREK RX BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. A 2.00X15MM NON-ABBOTT BALLOON AND 2.50X15MM XS [XIENCE SIERRA] STENT WAS DEPLOYED, 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 23882458 ↗