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

Model Number 777426

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Urinary Frequency (2275); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/27/2021

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 had an indwelling ureteral stent for drainage due to the operation of left kidney stone on (b)(6) 2021.Patient experienced hematuria, frequent urination, urgency, and dysuria repeatedly after the operation.The symptoms could be relieved by anti-inflammatory treatment, but they recurred from time to time.On (b)(6) 2022, the ureteral stent was removed.During the operation, the surface of the ureteral stent was covered with a large number of small stones, and there was a lot of pus moss on the surface.The patient experienced no significant discomfort after the surgery.It was mentioned that recurrent urinary tract infection and stone crystal deposition resulted due to foreign body reaction after indwelling the ureteral stent.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this event could be, "material selection".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." "potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislodgement, 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" "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating." h11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that the patient had an indwelling ureteral stent for drainage due to the operation of left kidney stone on (b)(6) 2021.Patient experienced hematuria, frequent urination, urgency, and dysuria repeatedly after the operation.The symptoms could be relieved by anti-inflammatory treatment, but they recurred from time to time.On (b)(6) 2022, the ureteral stent was removed.During the operation, the surface of the ureteral stent was covered with a large number of small stones, and there was a lot of pus moss on the surface.The patient experienced no significant discomfort after the surgery.It was mentioned that recurrent urinary tract infection and stone crystal deposition resulted due to foreign body reaction after indwelling the ureteral stent.

• 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: 13719978
• MDR Text Key: 286920346
• Report Number: 1018233-2022-01190
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

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: Lay User/Patient
• Device Model Number: 777426
• Device Catalogue Number: 777426
• Device Lot Number: NGFR5510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: 53 YR
• Patient Sex: Male