NICORE NITINOL GUIDEWIRE

Description of Event or Problem

IT WAS REPORTED THAT A PHYSICIAN PERFORMED A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE ON A PATIENT. AFTER OPENING THE GUIDEWIRE PACKAGING AS USUAL AND ACTIVATING THE COATING WITH STERILE WATER, THE GUIDEWIRE WAS INSERTED INTO THE PATIENT VIA A URETERAL CATHETER. THE URETEROSCOPE WAS THEN INSERTED ALONG THE GUIDEWIRE, AND DURING THE PROCEDURE, IT WAS OBSERVED THAT THE GUIDEWIRE COATING HAD PEELED OFF.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED 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.