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

Catalog Number 787622

Device Problems Break (1069); Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 08/20/2020

Event Type  Injury  

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 the distal tip of the stent got detached and the tip was removed using a ureteroscope.Per additional information received from the ibc via email on 07sep2020, the tip of the tiger tail ureteral catheter within the stent tray had broken off.The catheter was being used for ureterography to confirm if there were stones.After removal, the user noticed that the tip had broken off.The broken tip was removed from the patient using ureteroscope.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Based on the evaluation, it was observed that the tip of the tiger tail ureteral catheter was broken.The area of the breakage was evaluated under microscope and noted as a smooth tear.How and when the problem was occurred could not be determined.The lot number was unknown, and the information on the packaging lot number was not available.Therefore, the device history record could not be reviewed.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.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 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.

Event Description

It was reported that the distal tip of the stent was detached and the tip was removed using an ureteroscope.Per additional information received from the ibc via email on 07sep2020, the tip of the tiger tail ureteral catheter within the stent tray was broken off.The catheter was being used for ureterography to confirm whether there were stones in the ureter.After removal, the user noticed that the tip was broken off.The broken tip was removed from the patient using an ureteroscope.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE
• Type of Device: URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10569991
• MDR Text Key: 208084128
• Report Number: 1018233-2020-06136
• 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
• Report Date: 02/22/2021

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: 787622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 01/30/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention