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

Catalog Number	787626
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Urinary Frequency / Polyuria (2275); Hematuria (2558)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the patient underwent right transurethral ureteral stent placement in our hospital on (b)(6) due to ureteral stones.On (b)(6), patient was admitted to the hospital due to intermittent right-side low back pain, dark urine, and slight discomfort during urination.Urinalysis showed urinary tract infection, and the ureteral stent was removed on october 7.It was unknown what medical intervention was provided.Per follow up information received via ibc on 12nov2024, it was reported that the patient was admitted for ureteral stent placement in hospital for (left) due to ureteral stones on (b)(6).The patient had experienced slightly frequent urination and urgency, occasional gross hematuria, and left low back pain, and after visiting the hospital on the (b)(6) doctor took out the ureteral stent, gave anti-infection treatment, and was discharged after cure, and the doctor ordered the patient to follow up regularly in the later stage.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No additional actions can be taken at this time since root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: "indications for use: the inlay optima® ureteral stent and multi-length ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter.These conditions include stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.It is recommended that the indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.Contraindications: no known contraindications for use.Precautions: suture may be cut off prior to stent placement.Remove suture if indwelling time is expected to be longer than 14 days.Avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.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.* with any ureteral stent, migration is a possible complication, which could require medical intervention for removal.Selection of too short a stent may result in migration.Care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation.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 significant 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,; fistula formation ; loss of renal function fragmentation, migration, occlusion; hemorrhage; pain/discomfort; stent encrustation; hydronephrosis ; perforation of kidney, renal; ureteral erosion; infection pelvis, ureter and/or bladder ; urinary symptoms.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." udi format updated with available product information per gudid.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 or Problem Description
It was reported that the patient underwent right transurethral ureteral stent placement in our hospital on (b)(6) due to ureteral stones.On (b)(6), patient was admitted to the hospital due to intermittent right-side low back pain, dark urine, and slight discomfort during urination.Urinalysis showed urinary tract infection, and the ureteral stent was removed on (b)(6).It was unknown what medical intervention was provided.Per follow up information received via ibc on (b)(6) 2024, it was reported that the patient was admitted for ureteral stent placement in hospital for (left) due to ureteral stones on 04sep.The patient had experienced slightly frequent urination and urgency, occasional gross hematuria, and left low back pain, and after visiting the hospital on the (b)(6).The doctor took out the ureteral stent, gave anti-infection treatment, and was discharged after cure, and the doctor ordered the patient to follow up regularly in the later stage.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• 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: 20797495
• Report Number: 1018233-2024-07624
• Device Sequence Number: 15448783
• Product Code: FAD
• UDI-Device Identifier: 10801741015448
• UDI-Public: (01)10801741015448
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 787626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown