MINI TREK™ 1012402-15ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648180835), received between Jan 24, 2018 and Oct 27, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT IS 100% STENOSED. A 1.5X15MM MINI TREK II BALLOON DILATATION CATHETER WAS ADVANCED AND RESISTANCE WAS FELT WITH ANATOMY. ONCE AT THE LESION PRESSURE WAS ADDED AND AT THE SECOND INFLATION AT 12 ATMOSPHERES THE BALLOON RUPTURED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10741274 ↗
• MalfunctionJan 10, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RE-STENOSED LESION IN THE PROXIMAL DIAGONAL CORONARY ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. AN UNSPECIFIED MINI TREK OTW BALLOON DILATATION CATHETER (BDC) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AS IT MET RESISTANCE WITH AN UNSPECIFIED GUIDE WIRE. THE BDC WAS UNABLE TO BE REMOVED INDEPENDENTLY AND THEREFORE THE BDC AND GUIDE WIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. FOLLOWING RE-WIRING WITH AN NEW UNSPECIFIED GUIDE WIRE, A 1.50 X 15 MM MINI TREK II OTW BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER THE SAME PROBLEM OCCURRED. A NON-ABBOTT 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 Consequences Or Impact To Patient

  MAUDE report 8233660 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, TIGHT, LONG CIRCUMFLEX ARTERY (CX), SEVERAL ATTEMPTS WITH MULTIPLE SIZE DILATATION CATHETERS FAILED, BECAUSE THE DEVICES COULD NOT GET TO THE LESION. A GUIDELINER WAS USED WITH THE 1.5 X 15 MM MINITREK BALLOON DILATATION CATHETER AND AFTER INFLATION A LONG DISSECTION WAS NOTED IN THE CX AND OBTUSE MARGINAL ARTERIES. FRACTIONAL FLOW RESERVE (FFR) AND SURGICAL CONSULTATION DETERMINED THAT THE PATIENT WOULD BE TREATED WITH VESSEL BYPASS. THE PATIENT WAS TRANSFERRED FOR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7512636 ↗
• MalfunctionJan 24, 2018Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS ANTERIOR TIBIAL ARTERY. THE 1.5X15 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION FOR PRE-DILATATION. PRE-DILATATION WAS PERFORMED AND DURING REMOVAL OF THE BDC, RESISTANCE WAS FELT WITH THE ANATOMY. THE BDC WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7215171 ↗