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

Catalog Number	776428
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Critical care physician reported in a pmcf that stent was not successful in relieving ureteral obstruction to allow for urine drainage because "the splint occluded during the perioperative period" in relation to "776428 - inlaytm ureteral stent with nicore nitinol/nitinol guidewire,4.7 fr.,28cm".
Additional 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 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 or Problem Description
It was reported that the critical care physician reported in a pmcf that stent was not successful in relieving ureteral obstruction to allow for urine drainage because "the splint occluded during the perioperative period" in relation to "776428 - inlaytm ureteral stent with nicore nitinol/nitinol guidewire, 4.7 fr., 28 cm".
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "material selection part geometry" however, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "directions for 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.Submerge stent in sterile water to activate the coating.Insert the cystoscope then pass the guidewire through the scope until the tip is in the renal pelvis.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.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stents distal end marker reaches the ureterovesical junction (uvj).(see below for proper placement directions on the multi-length ureteral stent.) withdraw the guidewire slowly.The stent will form a pigtail automatically.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 first 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: 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.Fluoroscopy facilitates stent placement; however, standard radiography may be used.The suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument".H11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARD® INLAY® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Common Device Name: 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: 19007106
• Report Number: 1018233-2024-01703
• Device Sequence Number: 18487610
• Product Code: FAD
• UDI-Device Identifier: 10801741014212
• UDI-Public: (01)10801741014212
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 776428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown