MINI TREK™ 1012403-06ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648180859), received between May 27, 2021 and Feb 21, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2024Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO PERFORM ABLATION OF THE MARSHALL VEIN. THE 2.0 X 6 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS PURGED WITH HEPARINIZED WATER, INFLATED AND TESTED IN THE WATER BASIN UNDER POSITIVE PRESSURE BEFORE BEING PLACED IN THE PATIENT. AFTER THE BDC WAS ADVANCED, THE BALLOON RUPTURED AT A PRESSURE BETWEEN 4 AND 7 ATMOSPHERES. ANOTHER BALLOON WAS USED TO COMPLETE THIS PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751642 ↗
• MalfunctionOct 23, 2023Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MARSHALL VEIN. DURING PREPARATION THE 2.0X6.0MM MINI TREK II BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT 8 ATMOSPHERES. THEN, THE BALLOON WAS INTRODUCED IN THE PATIENT AND INFLATED ONCE AT 4 ATMOSPHERES WHEN A LEAK WAS NOTED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MIN DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17989207 ↗
• MalfunctionApr 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THE 2.00X6MM MINI TREK II OVER THE WIRE (OTW) BALLOON DILATATION CATHETER (BDC) WAS FOUND WITH A HOLE IN THE BALLOON WALL. THERE WAS NO NOTED DAMAGE TO THE OUTER PACKAGING. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER 2.00X6MM MINI TREK II BDC WAS USED FOR THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677611 ↗
• MalfunctionMar 15, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF TWO 2.00X6MM MINI TREK BALLOON DILATATION CATHETERS (BDC), THE DEVICES WERE NOT SOAKED IN A SALINE SOLUTION. ADDITIONALLY, THE BALLOONS WERE INFLATED OUTSIDE THE ANATOMY TO LESS THAN 4 ATMOSPHERES, TO ENSURE FUNCTIONALITY PRIOR TO USE. BOTH BALLOONS RUPTURED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547206 ↗
• MalfunctionMar 15, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF TWO 2.00X6MM MINI TREK BALLOON DILATATION CATHETERS (BDC), THE DEVICES WERE NOT SOAKED IN A SALINE SOLUTION. ADDITIONALLY, THE BALLOONS WERE INFLATED OUTSIDE THE ANATOMY TO LESS THAN 4 ATMOSPHERES, TO ENSURE FUNCTIONALITY PRIOR TO USE. BOTH BALLOONS RUPTURED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546622 ↗
• MalfunctionFeb 28, 2023Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MARSHALL VEIN/ATRIAL FIBRILLATION ABLATION. DURING PREPARATION OF THE 2.0X6 MM MINI TREK II BALLOON DILATATION CATHETER, THE DEVICE WAS NOT SOAKED IN A SALINE SOLUTION AND THE BALLOON IS INFLATED OUTSIDE THE ANATOMY TO LESS THAN 4 ATMOSPHERES. THEN THE BALLOON WAS ADVANCED TO THE VEIN AND WAS INFLATED ONCE TO 8 ATMOSPHERES; HOWEVER, A DISTAL BALLOON RUPTURE OCCURRED. 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 16455725 ↗
• MalfunctionJan 30, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE CUSTOMER DID NOT ACTIVATE THE BALLOON COATING IN A HEPARINIZED SALINE SOLUTION PER THE INSTRUCTIONS FOR USE. ALSO, THEY INFLATED THE BALLOON TO TEST IT BEFORE USING IT TO MAKE SURE IT WAS FULLY FUNCTIONAL BEFORE USING IT ON A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269657 ↗
• MalfunctionJan 30, 2023Break; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, THE BALLOON BROKE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION CAN OR WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269649 ↗
• MalfunctionJan 13, 2023Inflation Problem; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CORONARY SINUS VEIN. A 2X6MM MINI TREK II OVER THE WIRE (OTW) BALLOON DILATATION CATHETER (BDC) WAS DIFFICULT TO INFLATE AND THE BALLOON RUPTURED DURING INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162234 ↗
• InjuryAug 31, 2021Unintended System Motion; Material Separation; Unintended System Motion; Material Separation

  IT WAS REPORTED THAT A 2X6MM MINI TREK II BALLOON DILATATION CATHETER (BDC) MOVED UNINTENTIONALLY TWICE, AND A MARKER SEPARATED FROM THE DEVICE. THE MARKER REMAINS IN THE PATIENT ANATOMY, AND THE VEIN BECAME DAMAGED [DISSECTION], WHICH INTERFERED DURING CONTRAST MEDIA ADMINISTRATION. AN UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 12392978 ↗
• MalfunctionMay 27, 2021Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  THE FOLLOWING CORRECTED EVENT DESCRIPTION WAS RECEIVED STATING: THE PROCEDURE WAS PERFORMED TO TREAT A LEFT ARTERIAL FLUTTER. THE 2.00X6MM MINI TREK II OTW BALLOON DILATATION CATHETER LEAKED DURING USE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896061 ↗