NIAGARA

Description of Event or Problem

IT WAS REPORTED IN THE DEPARTMENT OF CRITICAL CARE MEDICINE, DURING THE INSERTION OF SHORT-TERM DIALYSIS CATHETERS, THE PHYSICIAN OBSERVED THAT THE GUIDEWIRE WAS PARTICULARLY PRONE TO KINKING, WHICH HINDERED SUCCESSFUL CATHETER PLACEMENT. AFTER THE GUIDEWIRE KINKED DURING THE PROCEDURE, THE PHYSICIAN HAD NO CHOICE BUT TO USE THE GUIDEWIRE FROM A CENTRAL VENOUS CATHETER (CVC) TO COMPLETE THE PLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.