GLIDEPATH

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE THROUGH THE LEFT JUGULAR VEIN USING THE GLIDEPATH HEMODIALYSIS CATHETER. DURING THE PROCEDURE, THE INSERTED GUIDEWIRE CAME OUT, AND UPON REINSERTION, IT STRAYED OUTSIDE THE VESSEL, RESULTING IN THE GLIDEPATH BEING POSITIONED OUTSIDE THE VESSEL. A CT SCAN CONFIRMED THAT THE ENTIRE CATHETER WAS OUTSIDE THE VESSEL FROM THE PUNCTURE SITE; THEREFORE, IT WAS DETERMINED THAT IT COULD BE SAFELY REMOVED. THE CATHETER WAS THEN REMOVED, AND THE PROCEDURE WAS CONCLUDED. THERE WAS NO REPORTED PATIENT INJURY.