BARD® INLAY® VERSA FIT® URETERAL STENT WITH NICORE¿ GUIDEWIRE

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

CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY A DR., IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE/HE ANSWERED "NO¿, TEMPORARILY, THE PRODUCT NATURALLY HELPED. OTHERWISE, FOR THE TIME BEING, HISTOLOGICAL CONFIRMATION AND TREATMENT OF THE A.E. MALIGNANT MASS IN THE URETER MUST BE CARRIED OUT.) ". ALSO, IN CHART 3, IN QUESTION: "PLEASE SPECIFY IF ANY OF THE FOLLOWING ADVERSE EVENTS OCCURRED AS A RESULT OF THE DEVICE (I.E. PLEASE INDICATE IF THE PATIENT EXPERIENCED ANY DEVICE RELATED ADVERSE EVENTS). " SHE/HE ANSWERED THE FOLLOWING AE: HEMATURIA, ALSO IN THE SAME CHART 3, THE RESPONDENT IN QUESTION "DID THE HEMATURIA RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION? OF NOTE: ANY ACTION AS A RESULT OF AN ADVERSE EVENT IS CONSIDERED MEDICAL INTERVENTION (E.G. PRESCRIBING ANY MEDICATION AS A RESULT OF AN ADVERSE EVENT, SURGERY AS A RESULT OF AN ADVERSE EVENT, ETC.)" SHE/HE ANSWERED WITH "NO". IN ADDITION IN CHART 3, IN QUESTION "DID THE PATIENT EXPERIENCE ANY OF THE FOLLOWING COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF INLAY VERSAFIT MULTI-LENGTH URETERAL STENT WITH NICORE GUIDEWIRE?" SHE/HE ANSWER WITH THE FOLLOWING COMPLICATIONS: HEMORRHAGE, INFECTION, THE CODE OF PRODUCT IS CHART 3-776400 CHART 4- 776428.

Description of Event or Problem

IT WAS REPORTED THAT CRITICAL CARE NURSE REPORTED IN CHART 4, IN THE ONLINE SURVEY, IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE/HE ANSWERED "NO¿ BECAUSE "THE PRODUCT PROVIDED TEMPORARY RELIEF! OTHERWISE, A HISTOLOGICAL CONFIRMATION AND TREATMENT OF THE SUSPECTED MALIGNANT MASS IN THE URETER MUST BE PERFORMED FOR THE TIME BEING.". ALSO, IN CHART 3, IN QUESTION: "PLEASE SPECIFY IF ANY OF THE FOLLOWING ADVERSE EVENTS OCCURRED AS A RESULT OF THE DEVICE (I.E. PLEASE INDICATE IF THE PATIENT EXPERIENCED ANY DEVICE RELATED ADVERSE EVENTS). " SHE/HE ANSWERED THE FOLLOWING AE: HEMATURIA, AND INFECTION (THE INFECTION IS ATTRIBUTABLE TO FOREIGN BODY-RELATED), ALSO IN THE SAME CHART 3, THE RESPONDENT IN QUESTION "DID THE HEMATURIA RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION? OF NOTE: ANY ACTION AS A RESULT OF AN ADVERSE EVENT IS CONSIDERED MEDICAL INTERVENTION (E.G. PRESCRIBING ANY MEDICATION AS A RESULT OF AN ADVERSE EVENT, SURGERY AS A RESULT OF AN ADVERSE EVENT, ETC.)" SHE/HE ANSWERED WITH "NO". IN ADDITION, IN CHART 3, IN QUESTION "DID THE PATIENT EXPERIENCE ANY OF THE FOLLOWING COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF INLAY VERSAFIT MULTI-LENGTH URETERAL STENT WITH NICORE GUIDEWIRE?" SHE/HE ANSWER WITH THE FOLLOWING COMPLICATIONS: HEMORRHAGE, INFECTION.

Additional Manufacturer Narrative

CORRECTIONS MADE TO TAB D,E,F. 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.