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

Catalog Number 787624

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

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 when placing a stent in a patient with ureteral stenosis, the stent was inserted through the guidewire end access into the ureteral catheter, advance it to the stricture site and inserted the guidewire into the renal pelvis.Gw tip becomes cork-like.It was smooth at that point, but the stent was inserted through the guidewire, but it did not progress.It was tried to remove the stent and guidewire once, but it got caught, in the situation of being forcibly withdrawn.A new guidewire was issued, and the stent was placed.

Manufacturer Narrative

The reported event was confirmed ¿ unknown cause.The reported failure was able to be reproduced.Observed the tip of guidewire was tangled.Visual inspection on guidewire surface observed no abnormality.How and when event are occurred could no be determine.The potential root cause for this failure mode could be generated at supplier site/mishandling by user.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: "[warnings] 1.Method for use (1)when using the multi-length type stent, it should be avoided in the following cases.1)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 part shave risks of knot formation at the tip of renal pelvis side during placement or removal.1) 2) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during 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.[contraindications] 1.Method for use (1)do not reuse.(2)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.] 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." 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.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that when placing a stent in a patient with ureteral stenosis, the stent was inserted through the guidewire end access into the ureteral catheter, advance it to the stricture site and inserted the guidewire into the renal pelvis.Gw tip becomes cork-like.It was smooth at that point, but the stent was inserted through the guidewire, but it did not progress.It was tried to remove the stent and guidewire once, but it got caught, in the situation of being forcibly withdrawn.A new guidewire was issued, and the stent was placed.

• 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: 16460389
• MDR Text Key: 310442995
• Report Number: 1018233-2023-01350
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 787624
• Device Lot Number: MYGV2099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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