NC TREK 1012443-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648151545), received between Dec 15, 2021 and Dec 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT CIRCUMFLEX TO THE MAIN CORONARY ARTERY. A 5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED THREE TIMES AT 12 ATMOSPHERES EACH. THE BDC WAS FULLY DEFLATED HOLDING NEGATIVE PRESSURE FOR 10-20 SECONDS EACH TIME. ONCE DEFLATED AND ATTEMPTED TO BE REMOVED, RESISTANCE WAS MET WITH AN UNSPECIFIED GUIDE CATHETER. THE BDC AND THE GUIDE CATHETER COULD NOT RETRACT INTO THE SHEATH; THEREFORE, A J WIRE WAS ADVANCED AND REMOVED THE SHEATH, BDC AND GUIDE CATHETER ALL AT ONCE. A NEW SHEATH WAS ADVANCED, BUT NO OTHER DEVICES WERE USED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012557 ↗