Samurai™ H74939302190J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729887836), received between Sep 4, 2019 and Jul 22, 2022 — classified as 1 injury, 2 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.

• InjuryJul 22, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE DETACHED AND REMAINED IN THE PATIENT. A 190CM SAMURAI GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS 40% STENOSED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED OSTIUM OF A DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD).THE GUIDEWIRE WAS USED TO DELIVER A STENT AND IT BECAME STUCK IN THE CORONARY AFTER THE STENT DEPLOYED AND RETRIEVAL WAS ATTEMPTED. THE PHYSICIAN TRIED TO PUSH THE DEVICE DISTALLY IN THE VESSEL BUT MOVEMENT WAS NOT SUCCESSFUL. THE DEVICE WAS ATTEMPTED TO BE PULLED, HOWEVER RESISTANCE WAS NOTED, AND A BALLOON WAS ADVANCED IN ORDER TO ATTEMPT TO MOVE THE DEVICE, WITHOUT SUCCESS. A FURTHER ATTEMPT WAS MADE TO PULL HARDER, HOWEVER, THE GUIDEWIRE BROKE ALONG THE RADIOPAQUE PORTION, AT AROUND 3 CM FROM THE TIP. THE PROXIMAL PART OF THE GUIDEWIRE WAS PULLED OUT, AND REMOVED SUCCESSFULLY. THE DISTAL PORTION OF THE GUIDEWIRE WAS LEFT INSIDE THE CORONARY OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL STENT AND NON-BOSTON SCIENTIFIC GUIDEWIRE. AN ADDITIONAL STENT WAS PLACED IN THE LEFT MAIN IN ORDER TO KEEP THE DETACHED PORTION O

  Patient problems: Foreign Body In Patient

  MAUDE report 15085588 ↗
• MalfunctionNov 18, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCUNTERED. A 190CM, J-TIP SAMURAI GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE WAS ENTANGLED AND WAS TRAPPED WITHIN THE LESION. IT WAS NOT SPECIFIED HOW THE GUIDEWIRE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335475 ↗
• MalfunctionSep 4, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-AUG-2019. IT WAS REPORTED THAT GUIDE WIRE DAMAGE OCCURRED. A 190CM SAMURAI GUIDE WIRE WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE GUIDE WIRE WAS DAMAGED DURING INTRODUCTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED WIRE CORE DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962179 ↗