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

Model Number 787700

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Event Description

It was reported that a physician stated in an online survey that no, the guidewire did not support stent placement procedure¿ because concrement located directly behind the bladder in relation to inlay optima® multi-length ureteral stent with hydroglide¿ guidewire, 7.0 fr., 22 ¿ 32cm.

Event Description

It was reported that a physician stated in an online survey that no, the guidewire did not support stent placement procedure¿ because concerment located directly behind the bladder in relation to inlay optima® multi-length ureteral stent with hydroglide¿ guidewire, 7.0 fr., 22 ¿ 32cm.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.It was unknown if the product meets specifications.Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review is not required as no lot number was reported.The instructions for use were found adequate and state the following: "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.1.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.2.Insert the cystoscope then pass the guidewire* through the scope until the tip is in the renal pelvis.3.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.4.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.5.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj) 6.Withdraw the guidewire slowly.The stent will form a pigtail automatically.7.Carefully remove the push catheter.Activate the guidewire coating according to the ¿instructions for use¿ found within the guidewire packaging".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.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT WITH 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: 16901631
• MDR Text Key: 314894571
• Report Number: 1018233-2023-03291
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015479
• UDI-Public: (01)10801741015479
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 787700
• Device Catalogue Number: 787700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other