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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD INLAY OPTIMA URETERAL STENT
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C.R. BARD, INC. (COVINGTON) -1018233 BARD INLAY OPTIMA URETERAL STENT Back to Search Results
Catalog Number 788626
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/26/2020
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 a black material was found near the ureteral inlet.When the user took it out with the endoscope and forceps, it looked like an end access tip of 5 mm was found.Per additional information via email from ibc on 09dec2020, patient impact and patient status was unknown.The tip was removed with a endoscopes and forceps.
 
Event Description
It was reported that a black material was found near the ureteral inlet.When the user took it out with the endoscope and forceps, it looked like an end access tip of 5 mm was found.Per additional information via email from ibc on 09dec2020, patient impact and patient status was unknown.The tip was removed with a endoscopes and forceps.
 
Manufacturer Narrative
The reported event was confirmed.The reported failure was able to be reproduced.The product was used for urological care.A potential root cause for this failure could be defect generated at supplier site and defective / torn / broken components.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: "[directions for use] 1.Method of use 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.1 insertion of the guidewire 1) remove the guidewire from the packaging,together with the guidewire holder.2) prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the hydrophilic coating.3) remove the guidewire from the guidewire holder.Before using the guidewire, confirm the surface slides well when removing it from the holder.If you feel any resistance, do not force it, and inject the normal saline solution into the holder again, then try pulling it out once more.4) insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.5) advance the guidewire into the desired position until the tip is in the renal pelvis.Continuously confirm guidewire position either visually or under fluoroscopy.2.Precautions for use (1)do not forcibly insert or remove the guidewire.It may injure patient or/and damage the device.(2)do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in damage the guidewire.Avoid contact with devices with sharp edges (such as metal dilator).(3)avoid using of the device when resistance is encountered (dueto the size of a catheter, stent and/or working-channel of endoscope) as this may cause wear the guidewire coating.(4)do not use organic medical solutions or oily contrast medium on this device.These solutions may damage the device or decrease the lubricity of the device.(5)the guidewire is treated with a hydrophilic coating.Do not insert a stent over the device with its surface insufficiently wet.Never use dry gauze.[hydrophilic polymer coating can be damaged, increasing resistance when trying to insert catheter, stent or endoscope.] (6)if unusual resistance is met during manipulation of the guidewire, do not force to remove it.Carefully withdraw the guidewire as a unit.(7)do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.(8)don¿t rub the guidewire with the edgeof the holder.This could flake the hydrophilic coating.(9)avoid kinking, bending or twisting repeatedly the guidewire at acute bent site.It may lead to damage the guidewire.(10)never try to shape the guidewire.This could damage and break the cable coreof the guidewire.(11)sufficient guidewire length must remain exposed to maintain a firm grip on the guidewire at all times." the actual/suspected device was evaluated.
 
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Brand Name
BARD INLAY OPTIMA URETERAL STENT
Type of Device
URETERAL STENT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11055027
MDR Text Key223141054
Report Number1018233-2020-21882
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2023
Device Catalogue Number788626
Device Lot NumberMYET3319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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