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

Model Number	788622
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that a calcified formation was observed on the ureteral stent upon removal from the patient.
Additional Manufacturer Narrative
The reported event was confirmed after the visual evaluation.However, the root cause was unknown.The sample presented calcification on the stent's surface.For functional testing, the calcification was removed from the stent.It was submerged under water for a short time and when the stent was taken out from the water, it was noticed that the coating had been activated and was present on the stent.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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 patients¿ 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." (b)(4).
Event or Problem Description
It was reported that a calcified formation was observed on the ureteral stent upon removal from the patient.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6810256
• Report Number: 1018233-2017-04370
• Device Sequence Number: 16180659
• Product Code: FAD
• UDI-Device Identifier: 00801741015748
• UDI-Public: (01)00801741015748
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2021
• Device Model Number: 788622
• Device Catalogue Number: 788622
• Device Lot Number: NGBQ3063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1