NIAGARA SLIMCATH, PC CATHETER SHAFT

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025, AT 10:00 AM, A TEMPORARY HEMODIALYSIS CATHETER WAS PLACED IN THE PATIENT'S JUGULAR VEIN TO SERVE AS THE DIALYSIS ACCESS. INITIAL PUNCTURE WAS SUCCESSFUL. HOWEVER, DURING CATHETER PLACEMENT, IT WAS FOUND THAT THE TEMPORARY TUBE COULD NOT BE PROPERLY INSERTED INTO THE JUGULAR VEIN. THE GUIDEWIRE WAS REPLACED WITH AN IODINE-3 GUIDEWIRE, BUT THE TEMPORARY HEMODIALYSIS CATHETER STILL COULD NOT BE PLACED SMOOTHLY. EXAMINATION REVEALED KINKING IN THE ANTERIOR SEGMENT OF THE CATHETER. AFTER REPLACING THE CATHETER WITH A NEW ONE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS.