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

Model Number 777626

Device Problem Biocompatibility (2886)

Patient Problems Urinary Frequency (2275); Hematuria (2558); Dysuria (2684)

Event Date 08/30/2021

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 was discharged from the hospital on (b)(6) 2021, with stenosis and obstruction.The patient had no symptoms of discomfort at the time of discharge.On (b)(6), the patient developed urgency, frequent urination, painful urination and other bladder irritation symptoms with naked eyes on the 6th day after the operation.Hematuria was observed and the patient was hospitalized on the same day.On (b)(6), the patient was given a urethral cystoscope to remove the indwelling right ureteral stent.After the operation, 2.0g of ceftriaxone sodium for injection was added to sodium chloride injection.Intravenous drip of 100ml twice a day, the patient's discomfort symptoms gradually relieved, and the discomfort symptoms such as urgency, frequent urination, painful urination, hematuria disappeared on (b)(6).

Manufacturer Narrative

The reported event was inconclusive since no sample was returned.A potential root cause for this event could be, "material selection".The device was not returned for evaluation.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: "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." "multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if signifi cant resistance is encountered during attempts at removal." "potential complications: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema, stone formation, peritonitis, extravasation, ureteral reflux, stent dislogdgement, fragmentation, migration, occlusion, fistula formation, loss of renal function, hemorrhage, pain/discomfort, stent encrustation, hydronephrosis, perforation of kidney, renal pelvis, ureter and/or bladder, ureteral erosion, infection, urinary symptoms" h11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the patient was discharged from the hospital on (b)(6), 2021, with stenosis and obstruction.The patient had no symptoms of discomfort at the time of discharge.On (b)(6), the patient developed urgency, frequent urination, painful urination and other bladder irritation symptoms with naked eyes on the 6th day after the operation.Hematuria was observed, and the patient was hospitalized on the same day.On (b)(6), the patient was given an urethral cystoscope to remove the indwelling right ureteral stent.After the operation, 2.0g of ceftriaxone sodium for injection was added to sodium chloride injection.Intravenous drip of 100ml twice a day, the patient's discomfort symptoms gradually relieved, and the discomfort symptoms such as urgency, frequent urination, painful urination, hematuria disappeared on (b)(6).

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12632526
• MDR Text Key: 276407192
• Report Number: 1018233-2021-06422
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• 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: 03/15/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGCZ3358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male