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

Model Number 777626

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Skin Discoloration (2074); Swelling/ Edema (4577)

Event Date 11/22/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient was admitted to the hospital due to difficulty in urinating.After admission, the doctor diagnosed benign prostatic hyperplasia, and at 10:20 on november 22, the patient was divided into an indwelling ureteral stent.At 17:00, the patient reported that the urethral orifice was painful and accompanied by white secretions.The doctor found that the urethral orifice was red and swollen after examination, so the ureteral stent was removed, and symptomatic anti-inflammatory treatment was given.At 8:30 on november 23, the doctor checked during the rounds.The patient's urethral orifice was normal and there was no secretion.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this event could be, "material selection".The device was used for treatment purposes, however, since the device was not returned it is unknown if it had met relevant specifications or contributed to 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: "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"."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 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.

Event Description

It was reported that the patient was admitted to the hospital due to difficulty in urinating.After admission, the doctor diagnosed benign prostatic hyperplasia, and at 10:20 on (b)(6), the patient was divided into an indwelling ureteral stent.At 17:00, the patient reported that the urethral orifice was painful and accompanied by white secretions.The doctor found that the urethral orifice was red and swollen after examination, so the ureteral stent was removed, and symptomatic anti-inflammatory treatment was given.At 8:30 on (b)(6), the doctor checked during the rounds.The patient's urethral orifice was normal and there was no secretion.

• 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: 13003180
• MDR Text Key: 282976757
• Report Number: 1018233-2021-08036
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGEW3164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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: 61 YR
• Patient Sex: Male