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

Catalog Number 786600

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive because poor sample condition.A potential root cause for this failure mode could be due to defect from vendor/operators handling method.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.Insertion of the guidewire: remove the guidewire from the packaging,together with the guidewire holder.Prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the hydrophilic coating.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.Insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.Advance the guidewire into the desired position until the tip is in the renal pelvis.Continuously confirm guidewire position either visually or under fluoroscopy.Precautions for use - guidewire: do not forcibly insert or remove the guidewire.It may injure patient or/and damage the device.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).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.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.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].If unusual resistance is met during manipulation of the guidewire, do not force to remove it.Carefully withdraw the guidewire as a unit.Do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.Do not rub the guidewire with the edge of the holder.This could flake the hydrophilic coating.Avoid kinking, bending or twisting repeatedly the guidewire at acute bent site.It may lead to damage the guidewire.Never try to shape the guidewire.This could damage and break the cable core of the guidewire.Sufficient guidewire length must remain exposed to maintain a firm grip on the guidewire at all times.".

Event Description

It was reported that a foreign material was found remaining in the bladder during lithoclast treatment using ureteral stent.It was unknown what the foreign material was.

Event Description

It was reported that a foreign material was found remaining in the bladder during lithoclast treatment using ureteral stent.It is unknown what the foreign material was.Per follow-up information received from ibc on 31oct2022,, stated that the detail about whether any additional procedure was done to remove the material wasn't provided from customer.

Manufacturer Narrative

The reported event was inconclusive because poor sample condition.It was unknown whether the product had caused the reported failure.Based on the evaluation, no abnormalities observed on sample returned, it was notice that foreign materials sample was not returned as per entry description mention.Further functional testing could not be performed.Therefore, the reported event is inconclusive due to poor sample condition.A potential root cause for this failure mode could be due to defect from vendor/operator's handling method.The lot number was unknown; therefore, the device history record could not be reviewed.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." 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.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH NICORE¿ 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15727915
• MDR Text Key: 306941886
• Report Number: 1018233-2022-08375
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 786600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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