NIAGARA SLIM-CATH

Description of Event or Problem

IT WAS REPORTED THAT GUIDEWIRE STUCK WITH NEEDLE. NO PATIENT INJURY WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED. 03/12/2026: THE RETURNED DEVICE EXHIBITED A BENT GUIDEWIRE.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF DIFFICULTY REMOVING THE INTRODUCER NEEDLE FROM THE GUIDEWIRE IS CONFIRMED AND WAS DETERMINED TO BE RELATED TO USE OF THE PRODUCT. ONE PINK 18 GA INTRODUCER NEEDLE AND ONE J-TIP GUIDEWIRE WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE RETURNED GUIDEWIRE AND INTRODUCER NEEDLE SHOWED BLOOD USE RESIDUES ALONG THE RETURNED DEVICES. THE PROXIMAL END OF THE GUIDEWIRE WAS OBSERVED TO BE BENT. A FUNCTIONAL TEST OF CAREFULLY AND FORCEFULLY REMOVING THE GUIDEWIRE FROM THE COMPLAINANT INTRODUCER NEEDLE REVEALED THE GUIDEWIRE COULD BE REMOVED WITH SOME DAMAGE TO THE CORE WIRE OF THE GUIDEWIRE. A FUNCTIONAL TEST OF ATTEMPTING TO INSERT THE DISTAL END OF THE COMPLAINANT GUIDEWIRE INTO A NON-COMPLAINANT 18 GA INTRODUCER NEEDLE REVEALED THE GUIDEWIRE WOULD NOT PASS OVER THE BLOOD RESIDUES OBSERVED AT THE DISTAL END OF THE DEVICE. A FUNCTIONAL TEST OF ATTEMPTING TO INSERT A NON-COMPLAINANT 0.038 IN. GUIDEWIRE INTO THE COMPLAINANT INTRODUCER NEEDLE REVEALED THE GUIDEWIRE WOULD STICK INSIDE THE INTRODUCER NEEDLE. THE GUIDEWIRE PASSED WITH SOME FORCE, AND USE RESIDUES EXITED THE INTRODUCER NEEDLE, ALLOWING THE NON-COMPLAINANT GUIDEWIRE TO PASS EASILY THROUGH THE COMPLAINANT INTRODUCER NEEDLE. A MICROSCOPIC OBSERVATION REVEALED ABUNDANT BLOOD RESIDUES ALONG THE GUIDEWIRE AND INTRODUCER NEEDLE. THE BLOOD APPEARED TO BE COAGULATED ALONG THE GUIDEWIRE CAUSING RESISTANCE IN THE INTRODUCER NEEDLE. THIS FAILURE WAS DETERMINED TO BE CAUSED BY EXCESSIVE USE RESIDUES INSIDE THE INTRODUCER NEEDLE AND ALONG THE GUIDEWIRE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.