NC TREK 1012451-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648152009), received between Apr 3, 2017 and Jun 21, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionJun 21, 2018Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X23MM NC TREK BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED TWICE, ONCE TO 18 ATMOSPHERES (ATM) AND ONCE TO 20 ATM. THE BALLOON WAS COMPLETELY DEFLATED PRIOR TO WITHDRAWAL. RESISTANCE WAS MET AT THE TIP OF THE 6FR GUIDING CATHETER AND THE NC TREK BALLOON COULD NOT BE COMPLETELY REMOVED. THE BALLOON CATHETER, GUIDING CATHETER, AND GUIDE WIRE WERE REMOVED AS A SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7627428 ↗
• MalfunctionMay 21, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL CORONARY ARTERY. THE 3.5X28 MM NC TREK WAS BEING LOADED ON TO THE GUIDE WIRE WHEN THE PROXIMAL SHAFT OF THE NC TREK SEPARATED IN TWO PIECES OUTSIDE THE ANATOMY. THE SEPARATED SEGMENT WAS MANUALLY REMOVED. ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530500 ↗
• InjuryApr 3, 2017Detachment Of Device Component; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 3.5 X 25 MM NC TREK BALLOON DILATATION CATHETER (BDC) TO THE LESION AND IT CROSSED SUCCESSFULLY; HOWEVER, DURING THE SECOND INFLATION AT OVER 12 ATMOSPHERES, THE BALLOON RUPTURED. WHEN THE BDC WAS BEING RETRACTED FROM THE LESION, RESISTANCE WAS FELT DUE TO THE CALCIFICATION AND THE BALLOON SEPARATED AND REMAINED IN THE RCA. A 3.5 X 38 MM XIENCE STENT DELIVERY SYSTEM (SDS) WAS USED TO STENT THE BALLOON TO THE VESSEL WALL. IT WAS FURTHER REPORTED THAT THE BALLOON WAS NOT SUBMERGED IN SALINE PRIOR TO USE. A NEW BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6455409 ↗