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

Model Number	788420
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	12/15/2020
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 due to bilateral ureteral stenosis, a ureteral stent was placed for drainage for the patient.During the placement of the ureteral stent, patient experienced intermittent gross hematuria, which was obvious after the activity and the patient returned to the hospital and was pulled out the bilateral ureteral stents.During the operation, a large number of stones were attached to the bladder section of the double j tube.The bilateral ureteral stents were taken out under direct ureteroscopy.No complaints were complained of postoperative discomfort.
Event or Problem Description
It was reported that due to bilateral ureteral stenosis, a ureteral stent was placed for drainage for the patient.During the placement of the ureteral stent, patient experienced intermittent gross hematuria, which was obvious after the activity and the patient returned to the hospital and was pulled out the bilateral ureteral stents.During the operation, a large number of stones were attached to the bladder section of the double j tube.The bilateral ureteral stents were taken out under direct ureteroscopy.No complaints were complained of postoperative discomfort.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "material selection".It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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." "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." 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® 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: 12071775
• Report Number: 1018233-2021-03821
• Device Sequence Number: 4004286
• Product Code: FAD
• UDI-Device Identifier: 00801741015656
• UDI-Public: (01)00801741015656
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Expiration Date: 09/13/2023
• Device Model Number: 788420
• Device Catalogue Number: 788424
• Device Lot Number: NGCZ3348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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: Required Intervention
• Patient Sex: Unknown