UNKNOWN DILATION PRODUCTS

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.

Description of Event or Problem

IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED TISSUE TRAUMA ASSOCIATED WITH USE OF THE X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER, ADDITIONALLY THE PHYSICIAN STATED THAT THE PATIENT REQUIRED MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF DEVICE USAGE, THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED FROM USAGE OF THE X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER WAS COAGULATION.