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

Model Number	778424
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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.
Event or Problem Description
It was reported that the stent was found in the abdomen outside the ureter.There was a pigtail catheter adjacent to the ureter.This was external to the ureter and not in bowel.Clinical correlation was recommended and this has been placed in the interval.
Event or Problem Description
It was reported that the stent was found in the abdomen outside the ureter.There was a pigtail catheter adjacent to the ureter.This was external to the ureter and not in bowel.Clinical correlation was recommended and this has been placed in the interval.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned.A potential root cause for this event could be, "design qualification" or "design output".The device was used for treatment purposes, however, it is unknown if the device had met relevant specifications or contributed to the reported event.No manufacturing issues or non-conformances were noted in the dhr review that could have caused or contributed to the reported event.Based on the results of the investigation 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: "with any ureteral stent, migration is a possible complication which could require medical intervention for removal.Selection of too short a stent may result in migration." "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage effi ciency and patient comfort.Submerge stent in sterile water to activate the coating." the device was not returned.

• Brand Name: BARD® INLAY® 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: 13102512
• Report Number: 1018233-2021-08497
• Device Sequence Number: 14301788
• Product Code: FAD
• UDI-Device Identifier: 00801741014758
• UDI-Public: (01)00801741014758
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 03/20/2022
• Device Model Number: 778424
• Device Catalogue Number: 778424
• Device Lot Number: NGBW3961
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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