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

Model Number	788400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2023
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.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.The device was not returned.
Event or Problem Description
It was reported that the patient experienced stone formation, ureteral reflux, pain or discomfort, perforation of kidney, renal pelvis, ureter and or bladder, infection, and urinary symptoms prior to the device placement, and pain or discomfort complications were directly attributable to the device and decrease if bladder size and urinary incontinence was needed in relation to inlay optima multi-length ureteral stent without guidewire, 4.7 fr, 22 -32cm.
Event or Problem Description
It was reported that the patient experienced stone formation, ureteral reflux, pain or discomfort, perforation of kidney, renal pelvis, ureter and or bladder, infection, and urinary symptoms prior to the device placement, and pain or discomfort complications were directly attributable to the device and decrease if bladder size and urinary incontinence was needed in relation to inlay optima multi-length ureteral stent without guidewire, 4.7 fr, 22 -32cm.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned.Although an exact root cause could not be determined a potential root cause could be material selection.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "precaution: ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.Warning: this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16901565
• Report Number: 1018233-2023-03289
• Device Sequence Number: 20537816
• Product Code: FAD
• UDI-Device Identifier: 00801741015632
• UDI-Public: (01)00801741015632
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043193
• 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): 08/15/2023

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: 788400
• Device Catalogue Number: 788400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/16/2023
• 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