MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® VERSA FIT® URETERAL STENT; INLAY URETERAL STENT

Model Number	778600
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the respondent mentioned stone formation , extravasation, ureteral reflux, stent dislodgement and migration, occlusion, pain, discomfort , stent encrustation , perforation of kidney, renal pelvis, ureter or bladder, ureteral erosion , infection , urinary symptoms when asked of complications while using the ureteral stent.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event is inconclusive.No sample was returned for evaluation.A potential root cause for this event could be, "material selection".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema,stone formation ,peritonitis,extravasation ,ureteral reflux, stent dislogdgement, fragmentation, migration, occlusion, fistula formation, loss of renal function , hemorrhage , pain/discomfort, stent encrustation , hydronephrosis, perforation of kidney, renal pelvis, ureter and/or bladder , ureteral erosion , infection ,urinary symptoms" "for single use only.Do not resterilize.Do not use if the package or product is damaged." 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the respondent mentioned stone formation, extravasation, ureteral reflux, stent dislodgement and migration, occlusion, pain, discomfort, stent encrustation, perforation of kidney, renal pelvis, ureter or bladder, ureteral erosion, infection, urinary symptoms when asked of complications while using the ureteral stent.It was unknown what medical intervention was provided.

• Brand Name: BARD® INLAY® VERSA FIT® URETERAL STENT
• Common Device Name: INLAY URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12693743
• Report Number: 1018233-2021-06615
• Device Sequence Number: 4613907
• Product Code: FAD
• UDI-Device Identifier: 00801741014789
• UDI-Public: (01)00801741014789
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 778600
• Device Catalogue Number: 778600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown