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

Model Number	787700
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2021
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 ureteral stent had caused infection.It was unknown what medical intervention was provided for the infection.
Event or Problem Description
It was reported that the ureteral stent had caused infection.It was unknown what medical intervention was provided for the infection.
Additional Manufacturer Narrative
The reported event is inconclusive since no sample was returned.A potential root cause for this event could be, "material selection".The device was used for treatment purposes, however, it is unknown if it had met relevant specifications or contributed to the reported event.A dhr review is not required as the lot number is unknown.Based on the results of the investigation, no additional action is required at this time.The device was not returned for evaluation.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: "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." "potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema , stone formation , peritonitis , extravasation , ureteral reflux , stent "dislodgement", 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" "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." 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.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: 12786077
• Report Number: 1018233-2021-07065
• Device Sequence Number: 4005134
• Product Code: FAD
• UDI-Device Identifier: 10801741015479
• UDI-Public: (01)10801741015479
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/17/2022

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: 787700
• Device Catalogue Number: 787700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 04/13/2022
• 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