MINI TREK™ 1012402-06ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648180804), received between Sep 13, 2018 and Mar 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT CIRCUMFLEX (MLCX) WITH HEAVY CALCIFICATION. THE 1.5X6MM MINI TREK II BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL, HOWEVER, THE DEVICE WAS REMOVED INDEPENDENTLY. THERE WERE NO OTHER DEVICE ISSUES NOTED. A NON-ABBOTT BALLOON WAS USED TO CONTINUE 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 16628842 ↗
• MalfunctionSep 24, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED DISTAL RIGHT CORONARY ARTERY. A 1.5X6MM MINI TREK II BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATATION BUT HAD DIFFICULTY BEING REMOVED DUE TO THE ANATOMY, SO THE BDC WAS REMOVED WITH THE UNSPECIFIED GUIDE WIRE. AN UNSPECIFIED BDC AND UNSPECIFIED STENT WERE USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 10583802 ↗
• MalfunctionSep 13, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS MILDLY TORTUOUS, MODERATELY CALCIFIED AND 100% STENOSED. A 1.5 X 6 MM MINI TREK II BALLOON CATHETER RUPTURED AT APPROXIMATELY 8 ATMOSPHERES DURING THE FIRST INFLATION. THERE WAS RESISTANCE REPORTED DURING ADVANCEMENT TO THE LESION. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. A NON-ABBOTT OVER THE WIRE DILATATION BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874359 ↗