BARD® X-FORCE® BALLOON DILATION CATHETER

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.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT URETERAL LITHOTRIPSY AND LITHOTRIPSY FOR RENAL CALCULI, DUE TO THE PATIENT'S COMBINED STENOSIS WAS PLANNED TO BE DILATED USING THE BALLOON KIT 998806, THE SURGICAL STEPS WENT TO THE BALLOON DILATATION SESSION, IMPLANTATION OF THE BALLOON WAS PLANNED FOR URETERAL DILATATION, AND DILATATION WAS PERFORMED WITH A PNEUMATIC PUMP, AND THE PUMP WAS FOUND TO HAVE A LEAK, THE EXACT ORIGINAL WAS UNKNOWN. THE HOSPITAL ROUTINELY USE BALLOON, BALLOON USE EXPERIENCE. CLINICAL JUDGMENT AFTER THE CHOICE OF A NEW SET OF BALLOON, THE PRODUCT WITHOUT PROBLEMS SUCCESSFULLY COMPLETED THE FOLLOW-UP OPERATION, THE OPERATION WAS SUCCESSFULLY COMPLETED.