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

Model Number	778600
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
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" or "part geometry".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"."the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." "directions for use: 1.Determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating.2.Insert the cystoscope then pass the guidewire* through the scope until the tip is in the renal pelvis.3.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.4.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.5.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj).6.Withdraw the guidewire slowly.The stent will form a pigtail automatically.7.Carefully remove the push catheter." 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: 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: 12681554
• Report Number: 1018233-2021-06547
• Device Sequence Number: 11057592
• 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): 03/22/2022

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: 03/22/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 04/15/2022
• 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