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

Model Number 778426

Device Problem Calcified (1077)

Patient Problems Fever (1858); Chills (2191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/08/2022

Event Type  Injury  

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 patient underwent right ureteroscopic right ureteral lithotripsy on (b)(6) 2021, and a right ureteral stent was placed during the operation.On (b)(6) 2022, the right ureteral stent was removed by cystoscopy.The stent tube could not be pulled out after half of the stent tube was pulled out.The stent tube was found to have stones and floccules under the microscope, and the extubation was stopped, and the hospitalization procedures were completed.It was planned to sent the patient to the operating room for ureteral lithotripsy and stent removal.At 8:00 on (b)(6), the patient developed chills and high fever.The symptoms did not improve after anti-infective treatment and fluid replacement therapy, and the operation was suspended.At 17:54 on (b)(6), the patient developed septic shock.After active rescue and treatment, there was no significant improvement.At 00:53 on (b)(6), the patient was transferred to icu for emergency treatment.

Event Description

It was reported that the patient underwent right ureteroscopic right ureteral lithotripsy on (b)(6) 2021, and a right ureteral stent was placed during the operation.On (b)(6) 2022, the right ureteral stent was removed by cystoscopy.The stent tube could not be pulled out after half of the stent tube was pulled out.The stent tube was found to have stones and floccules under the microscope, and the extubation was stopped, and the hospitalization procedures were completed.It was planned to sent the patient to the operating room for ureteral lithotripsy and stent removal.At 8:00 on (b)(6), the patient developed chills and high fever.The symptoms did not improve after anti-infective treatment and fluid replacement therapy, and the operation was suspended.At 17:54 on (b)(6), the patient developed septic shock.After active rescue and treatment, there was no significant improvement.At 00:53 on (b)(6), the patient was transferred to icu for emergency treatment.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned for evaluation and further investigation was not conclusive.Based on the risk management file a potential root cause for this event could be, "material selection", however, there is not enough information in the event to confirm this cause.The device was used for treatment purposes.As the device was not returned for evaluation it is unknown if it had met all 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." correction: b,g.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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15293388
• MDR Text Key: 298586451
• Report Number: 1018233-2022-06655
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 778426
• Device Catalogue Number: 778426
• Device Lot Number: NGFP0945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female