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

Model Number 778426

Device Problem Incorrect Measurement (1383)

Patient Problem Swelling/ Edema (4577)

Event Date 10/19/2022

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 ureteral stent was used after flexible ureteroscope holmium laser lithotripsy to maintain ureteral patency and to drain kidney urine.One month after the operation, it was found that the proximal end of the ureteral stent was displaced to the upper end of the ureter and could not be suspended in the renal pelvis.This resulted in poor renal urine drainage and hydronephrosis.The ureteral stent was removed.No medical intervention was reported.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation.The device was used for treatment purposes.As the device was not returned for evaluation it is unknown if it had met relevant specifications or resulted in the reported event.As the sample was not returned for evaluation a specific root cause could not be determined.However, based on the risk document a potential root cause for this failure could be, "material selection, part geometry".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.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 the ureteral stent was used after flexible ureteroscope holmium laser lithotripsy to maintain ureteral patency and to drain kidney urine.One month after the operation, it was found that the proximal end of the ureteral stent was displaced to the upper end of the ureter and could not be suspended in the renal pelvis.This resulted in poor renal urine drainage and hydronephrosis.As per the analysis and description of the cause of the incident, it was stated that the diameter of the proximal panel circle of the ureteral stent is small, and it is difficult to stably fix it in the renal pelvis.The ureteral stent was removed.No medical intervention was reported.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15723369
• MDR Text Key: 307214457
• Report Number: 1018233-2022-08377
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014765
• UDI-Public: (01)00801741014765
• 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: 11/20/2022

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: 09/21/2023
• Device Model Number: 778426
• Device Catalogue Number: 778426
• Device Lot Number: NGDN0942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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: 50 YR
• Patient Sex: Male