NIAGARA

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 RECEIVED BY 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.

Description of Event or Problem

IT WAS REPORTED PATIENT WITH RENAL INSUFFICIENCY, UREMIA, OR HYPERKALEMIA REQUIRE HEMODIALYSIS TREATMENT. DURING ULTRASOUND-GUIDED CATHETER PLACEMENT, THE PHYSICIAN SUCCESSFULLY PERFORMED THE PROCEDURE WITH ADEQUATE BLOOD RETURN AND SMOOTH GUIDEWIRE PLACEMENT. HOWEVER, WHEN ATTEMPTING TO INSERT THE DILATOR AFTER INCISION AT THE PUNCTURE SITE, THE GUIDEWIRE KINKED (OR, ALTERNATIVELY, WHILE DILATOR INSERTION PROCEEDED SMOOTHLY, THE CATHETER COULD NOT ADVANCE DUE TO GUIDEWIRE KINKING DURING CATHETER PLACEMENT). THE PHYSICIAN IMMEDIATELY SWITCHED TO A GUIDEWIRE FROM A DIFFERENT DISPOSABLE STERILE CENTRAL VENOUS CATHETER TO COMPLETE THE PLACEMENT.