BARD® INLAY® URETERAL STENT

Additional Manufacturer Narrative

THE INITIAL REPORTER'S PHONE NUMBER: (B)(6). 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: SECTIONS 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 BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY AND STATED THAT IN CHART 4, IN THE ONLINE SURVEY A DR. 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 OR HE ANSWERED THE FOLLOWING AES: CHART 4 URINARY SYMPTOMS. ALSO THE RESPONDENT IN QUESTION "DID THE URINARY SYMPTOMS 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 OR HE ANSWERED WITH "YES", ALSO THE DR. IN QUESTION "PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED FROM" SHE OR HE ANSWERED THE FOLLOWING: A SPECIFIC COMPANY. IN ADDITION, IN QUESTION "DID THE PATIENT EXPERIENCE ANY OF THE FOLLOWING COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF INLAY URETERAL STENT WITHOUT GUIDEWIRE?" SHE OR HE ANSWER WITH THE FOLLOWING COMPLICATIONS: LOSS OF RENAL FUNCTION AND INFECTION. THE CODE OF PRODUCT IS CHART 4 778622.