NiCore Nitinol Guidewire

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6). 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.

Description of Event or Problem

IT WAS REPORTED THAT, THE PHYSICIAN OPENED THE GUIDEWIRE PACKAGING, REMOVED THE PROTECTIVE CAP FROM THE GUIDEWIRE TIP, AND DISCOVERED THAT THE COATING ON THE TIP HAD PEELED OFF, RENDERING THE GUIDEWIRE UNUSABLE.