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

Model Number 778626

Device Problem Nonstandard Device (1420)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported that at 15:28 on (b)(6), 2022, the medical staff took out the ureteral stent for the patient and found that the stones were formed attached the wall of stent.Also stated that the surface coating of the ureteral stent was damaged, leading to the formation of stones and the patient had a stone constitution, and drinking less water causes the urine to concentrate and crystallize to form stones.Advised the patient to drink plenty of water and give symptomatic and supportive treatment.

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 Description

It was reported that at 15:28 on (b)(6) 2022, the medical staff took out the ureteral stent for the patient and found that the stones were formed attached to the wall of the stent.It was also stated that the surface coating of the ureteral stent was damaged, leading to the formation of stones and the patient had a stone constitution, and drinking less water causes the urine to concentrate and crystallize to form stones.Advised the patient to drink plenty of water and give symptomatic and supportive treatment.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned, and further investigation was not conclusive.Though a specific cause cannot be determined, a potential root cause for this event could be, "material selection".The device was used for treatment purposes.It is unknown if the device had met relevant specifications or resulted in the reported event.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: "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 patient¿s 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." 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.H3 other text: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15986388
• MDR Text Key: 308031449
• Report Number: 1018233-2022-09535
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014833
• UDI-Public: (01)00801741014833
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

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 Model Number: 778626
• Device Catalogue Number: 778626
• Device Lot Number: NGFT5440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Female