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

Model Number	233724
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ureteral stent was broken into three pieces during removal.The device was implanted on (b)(6) 2021 and removed on (b)(6) 2021.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the ureteral stent was broken into three pieces during removal.The device was implanted on (b)(6) 2021 and removed on (b)(6) 2021.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.1 sample was confirmed to exhibit the reported failure.A potential root cause for this failure could be packaging pattern not followed.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: (open end) 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.Preloaded stent with clamp 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Place guidewire into distal (bladder) end of stent.Advance guidewire to the proximal end of the stent.If stiff end of guidewire is used, do not allow guidewire tip to extend past proximal tip of stent.(this will help keep stent in place for insertion.) 3.Place push catheter on guidewire until it abuts distal end of stent.4.Place small white clamp at most distal end of push catheter and clamp securely (see fig.1).This will ensure correct positioning of stent on the push catheter during insertion procedure.5.Insert stent.6.When placement is complete, release clamp by pushing top portion back and remove from push catheter (see fig.2).7.Hold push catheter and remove guidewire.The stent retention loop will form spontaneously.Then carefully remove push catheter from cystoscope.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction using endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.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." the actual/suspected device was inspected.

• Brand Name: BARD® FLUORO-4¿ SILICONE URETERAL STENT
• Common Device Name: URETERAL STENT (SILICONE)
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12782465
• Report Number: 1018233-2021-07106
• Device Sequence Number: 20271064
• Product Code: FAD
• UDI-Device Identifier: 10801741011716
• UDI-Public: (01)10801741011716
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K823487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 07/28/2025
• Device Model Number: 233724
• Device Catalogue Number: 233724
• Device Lot Number: NGFN4306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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