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

Catalog Number 778626

Device Problem Calcified (1077)

Patient Problems Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, the patient underwent surgical treatment and the ureteral stent was removed.During the process, it was found that calculus formed on the wall of part of the ureteral stent, the segment in the bladder, which was difficult to remove.It was stated that the patient's pain and discomfort increased during the operation.No medical intervention was reported.Per additional information via email from ibc on 07jul2023, it was stated that the stone volume was large, the stent removal was difficult, and the pain and discomfort of patients were increased.Additional medical measures were taken, and the stent was removed with the soft mirror crushing the stone.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for investigations.Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review is not required as no lot number was reported for this investigation.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.

Event Description

It was reported that on (b)(6) 2023, the patient underwent surgical treatment and the ureteral stent was removed.During the process, it was found that calculus formed on the wall of part of the ureteral stent, the segment in the bladder, which was difficult to remove.It was stated that the patient's pain and discomfort increased during the operation.Per additional information via email from ibc on 07jul2023, it was stated that the stone volume was large, the stent removal was difficult, and the pain and discomfort of patients were increased.Additional medical measures were taken, and the stent was removed with the soft mirror crushing the stone.

• 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: 17377521
• MDR Text Key: 319745148
• Report Number: 1018233-2023-05427
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 778626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention