MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD INLAY URETERAL STEN; URETHRAL STENT

Model Number 778624

Device Problem Biocompatibility (2886)

Patient Problems Irritation (1941); Skin Inflammation/ Irritation (4545)

Event Date 10/16/2020

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 patient experienced urticaria and hives with urethral stent.As per the follow up, the stent was in place for 2 days before the symptoms started.The stent is reportedly still in place.The patient was treated with antihistamines such as hydroxyzine.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be " material selection".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: ¿directions for use: 1.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.Submerge stent in sterile water to activate the coating.2.Insert the cystoscope then pass the guidewire through the scope until the tip is in the renal pelvis.3.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.4.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.5.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj).(see below for proper placement directions on the multi-length ureteral stent.) 6.Withdraw the guidewire slowly.The stent will form a pigtail automatically.7.Carefully remove the push catheter.Activate the guidewire coating according to the ¿instructions for use¿ found within the guidewire packaging.Multi-length ureteral stent placement: to accurately size this stent count the marker bands as it is being advanced into the ureter.The fi rst large band indicates the 22cm length.The second and third bands indicate 24cm and 26cm lengths respectively.The last large band is the 28cm length.If you need to place for the 30cm and 32cm lengths, use the attached suture or endoscopic forceps to gently pull back on the stent unwinding the coil from the kidney.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction on the suture or by use of endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.The suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations." 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 patient experienced urticaria and hives with urethral stent.As per the follow up, the stent was in place for 2 days before the symptoms started.The stent is reportedly still in place.The patient was treated with antihistamines such as hydroxyzine.

• Brand Name: BARD INLAY URETERAL STEN
• Type of Device: URETHRAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10813539
• MDR Text Key: 215476535
• Report Number: 1018233-2020-20825
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 778624
• Device Catalogue Number: 778624
• Device Lot Number: NGER1685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention