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

Model Number 777426

Device Problem Calcified (1077)

Patient Problems Micturition Urgency (1871); Urinary Frequency (2275); Dysuria (2684)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of 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.

Event Description

It was reported that the patient was sent to the operating room at 09:50 on (b)(6) 2022, due to stones in the lower segment of the right ureter for transurethral right ureteroscopy, lithotripsy and ureteral stent placement.After the stone was removed, the "ureteral stent" was inserted into the lateral ureter to dilate the ureter and prevent postoperative ureteral stenosis and obstruction.The operation went well and the patient was discharged from the hospital on (b)(6) 2022, and there was no discomfort at the time of discharge.On (b)(6), 10 days after the operation, the patient got urinary urgency, frequent urination, dysuria, painful urination, along with bladder irritation, pain and gross hematuria in waist and abdomen.On october 9th, he was hospitalized and underwent a transurethral cystoscope to remove the "ureteral stent" indwelling in the right ureter.During the operation, it was found that some stones were adhered to the end surface of the ureteral stent in the bladder, which was at the end of the ureteral stent outside the ureteral orifice.250ml of 0.2% lactate levofloxacin sodium chloride injection was given intravenously after surgery, once a day, the above symptoms were gradually relieved after anti-inflammatory treatment, and the symptoms of urgency, frequent urination, dysuria, and hematuria disappeared in the afternoon of (b)(6).The patient was discharged in the afternoon.

Event Description

It was reported that the patient was sent to the operating room at 09:50 on (b)(6) 2022, due to stones in the lower segment of the right ureter for transurethral right ureteroscopy, lithotripsy and ureteral stent placement.After the stone was removed, the "ureteral stent" was inserted into the lateral ureter to dilate the ureter and prevent postoperative ureteral stenosis and obstruction.The operation went well and the patient was discharged from the hospital on (b)(6) 2022, and there was no discomfort at the time of discharge.On (b)(6) 10 days after the operation, the patient got urinary urgency, frequent urination, dysuria, painful urination, along with bladder irritation, pain and gross hematuria in waist and abdomen.On (b)(6) he was hospitalized and underwent a transurethral cystoscope to remove the "ureteral stent" indwelling in the right ureter.During the operation, it was found that some stones were adhered to the end surface of the ureteral stent in the bladder, which was at the end of the ureteral stent outside the ureteral orifice.250ml of 0.2% lactate levofloxacin sodium chloride injection was given intravenously after surgery, once a day, the above symptoms were gradually relieved after anti-inflammatory treatment, and the symptoms of urgency, frequent urination, dysuria, and hematuria disappeared in the afternoon of (b)(6).The patient was discharged in the afternoon.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned, and further investigation was not conclusive.Although a specific cause cannot be determined, a potential cause for this event could be, "material selection." the device was used for treatment purposes.It is unknown if the device had met all relevant specifications or resulted in the reported event.No manufacturing issues or non-conformances were noted during review of the dhr 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 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.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: 15885824
• MDR Text Key: 304517639
• Report Number: 1018233-2022-09078
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014489
• UDI-Public: (01)10801741014489
• 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: 03/14/2023

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: 777426
• Device Catalogue Number: 777426
• Device Lot Number: NGEZ3562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 56 YR
• Patient Sex: Female