MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 6 FR. X 26CM; INLEY OPTIMA STENT

Catalog Number 788626

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the coating was peeled off from the guidewire on the day of surgery.When the physician found it, he stopped using the guidewire.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the coating was peeled off from the guidewire on the day of surgery.When the physician found it, he stopped using the guidewire.

Event Description

It was reported that the coating was peeled off from the guidewire on the day of surgery.When the physician found it, he stopped using the guidewire.

Manufacturer Narrative

Received only the guidewire for evaluation.The evaluation confirmed that no abnormalities were found as per the reported event, compared with a good unit.Therefore, this complaint was unconfirmed.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 percutaneous, 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.".

• Brand Name: INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 6 FR. X 26CM
• Type of Device: INLEY OPTIMA STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7741959
• MDR Text Key: 115916284
• Report Number: 1018233-2018-03234
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

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: 788626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 10/11/2018
• Supplement Dates FDA Received: 08/03/2018; 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1