UNKNOWN DILATION PRODUCTS

Description of Event or Problem

IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY ON BEHALF OF A RESPONDENT THAT INDICATED THE FOLLOWING COMPLAINT IN AN ONLINE CHART AUDIT: IN THE ONLINE SURVEY A PHYSICIAN STATED THAT NO, HE/SHE WAS NOT ABLE TO SUCCESSFULLY DILATE THE NEPHROSTOMY TRACT BECAUSE "KEINE". ADDITIONALLY, THE PHYSICIAN STATED THAT NO, THE PATIENT WAS NOT STONE FREE AT PROCEDURE COMPLETION. IN RELATION TO X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER WITH EAGLE INFLATION DEVICE.

Additional Manufacturer Narrative

OUR TEAM CONDUCTED A REVIEW OF THE REPORTED EVENT, WITH THE AVAILABLE INFORMATION TO ENSURE THE ONGOING SAFETY AND PERFORMANCE OF THE PRODUCT. AS THIS INVESTIGATION HAS ALREADY BEEN PERFORMED FOR A SIMILAR COMPLAINT, ANOTHER INVESTIGATION IS NOT NECESSARY. AN INVESTIGATION HAS BEEN COMPLETED USING ALL INFORMATION CURRENTLY AVAILABLE. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST-MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.