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

Catalog Number 787626

Device Problem Flaked (1246)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the coating of the end access guidewire was peeled off.The peel retained in the patients body.It is unknown what medical intervention was provided.

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 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the coating of the end access guidewire was peeled off.The peel retained in the patient's body.

Event Description

It was reported that the coating of the end access guidewire was peeled off.The peel retained in the patient's body.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could be defect from supplier (defective/broken components).The device was not returned for evaluation.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: "warning: method for use 1) when using the multi-length type stent, it should be avoided in the following cases.- if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil parts have risks of knot formation at the tip of renal pelvis side during placement or removal.- if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive forceduring removal may lead to damage of the renal pelvis and/or ureter.2) ureteroarterial fistula may be formed between the ureter and the aorta or the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care.Contradictions: 1.Method for use - do not reuse - do not resterilize 2.Applicable patients do not use for the woman who is pregnant or may become pregnant.[to avoid radiation exposure on pre-born baby from x-ray.] 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 5 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.Precautions: 1.Important precautions (1)the stent is not intended as a permanent indwelling device.It is recommended that the indwelling time not exceed 365 days.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.[all stents may be subject to varying degrees of encrustation when placed in the urinary tract.Encrustation may result in occlusion of the stent or pain or discomfort for the patient.] 2.Malfunction and adverse events (1)malfunction ¿fragmentation, damage ¿guidewire kinking ¿difficulty in insertion ¿difficulty in removal ¿occlusion ¿migration ¿encrustation ¿difficulty in removal of the stent due to knotting of the coil1) (2) adverse events ¿edema ¿loss of renal function ¿extravasation ¿pain/discomfort ¿fistula formation ¿perforation of kidney, renal pelvis, ureter and/or bladder ¿hemorrhage ¿peritonitis ¿hydronephrosis ¿infection ¿stone formation ¿urethral erosion ¿urethral reflux ¿separated piece remaining in body" 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 URETERAL STENT WITH HYDROGLIDE GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11812169
• MDR Text Key: 250213389
• Report Number: 1018233-2021-02727
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 787626
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/28/2021; 08/02/2021
• Supplement Dates FDA Received: 06/24/2021; 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other