MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FLUORO-4 SILICONE URETERAL STENT

Model Number	233626
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the front tip of the stent was found to be broken.They stated that another new d-j was used.
Event or Problem Description
It was reported that the front tip of the stent was found to be broken.They stated that another new d-j was used.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "inappropriate package design".The device was not returned for evaluation.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.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Pass the guidewire flexible tip beyond the obstruction to the renal pelvis.Note: tortuosity in the obstructed ureter can often be resolved using the guidewire and open end ureteral catheter in combination.3.Pass the stent over the guidewire through the cystoscope, advancing it into the ureter with the push catheter under direct vision.Assistant holds the guidewire in position to prevent advancement of the wire into the renal parenchyma.4.Watch for the distal end of the stent at the ureterovesical junction.Stop advancement of the stent at that point.Assistant removes the guidewire as the operator holds the stent in position with the push catheter.The retention coil will form spontaneously.Carefully remove the push catheter from the cystoscope.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.H3 other text : the device was not returned.

• Brand Name: BARD FLUORO-4 SILICONE URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12045824
• Report Number: 1018233-2021-03712
• Device Sequence Number: 3503359
• Product Code: FAD
• UDI-Device Identifier: 10801741011686
• UDI-Public: (01)10801741011686
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K823487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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 Expiration Date: 11/28/2024
• Device Model Number: 233626
• Device Catalogue Number: 233626
• Device Lot Number: NGEP0474
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other