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

Model Number 778424

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 287018211
• Report Number: 1018233-2021-08497
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014758
• UDI-Public: (01)00801741014758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other