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

Catalog Number 787624

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that the tigertail ureteral catheter connector was stiff and did not advance.Stated that this had been happening continuously recently.

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.

Manufacturer Narrative

The reported event was confirmed and unknown cause.The reported failure was able to be reproduced.Assemble the components and move the adapter through the tiger tail.And found that the ureteral catheter required strong force to pass through the touhy bourst adapter.Then, each part of touhy bourst adapter (hub, seal, and collect) was dismantled and move through the tiger tail one by one.It was found that the seal part was difficult to move and had caused the issue.Meanwhile, there were no issue with other part (hub and connect).A potential root cause for this failure mode could be defects component from supplier.The lot number is 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 (due to 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 edge of 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 core of the guidewire.(11)sufficient guidewire length must remain exposed to maintain a firm grip on the guidewire at all times." 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 tigertail ureteral catheter connector was stiff and did not advance.Stated that this had been happening continuously recently.

Manufacturer Narrative

The reported event was confirmed and unknown cause.Assemble the components and move the adapter through the tiger tail.And found that the ureteral catheter required strong force to pass through the touhy bourst adapter.Then, each part of touhy bourst adapter (hub, seal, and collect) was dismantled and move through the tiger tail one by one.It was found that the seal part was difficult to move and had caused the issue.Meanwhile, there were no issue with other part (hub and connect).A potential root cause for this failure mode could be defects component from supplier.The lot number is 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 (due to 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 edge of 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 core of 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 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 actual/suspected device was inspected.

Event Description

It was reported that the tigertail ureteral catheter connector was stiff and did not advance.Stated that this had been happening continuously recently.As per follow-up information received from ibc on 01dec2023, stated that the defect was found before use.

• Brand Name: BARD® INLAY OPTIMA® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18184920
• MDR Text Key: 328701365
• Report Number: 1018233-2023-08399
• 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,Followup
• Report Date: 12/13/2023

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 Catalogue Number: 787624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 12/13/2023
• Supplement Dates FDA Received: 12/11/2023; 12/15/2023
• 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