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

Model Number	778624
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor was placing an 6fr inlay ureteral stent after a ureteroscopy, but the stent would not advance over a solo flex 0.38 guidewire.After opening another 6fr inlay ureteral stent, the doctor was easily able to backload the stent into the patient over the same solo flex 0.38 guidewire.The determination was that the stent was defective.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent was returned without the original packaging.An evaluation was completed by futurematrix on 22sep2022.Unknown black flaking was present in the ziploc bag with the sample.The suture was observed to be tied and cut off, this is not the way the suture is placed on the stent during assembly.The tip of the proximal end of the stent appear to have notches in no certain pattern, as this was not reported by the customer and it is unknown if these notches were put in the stent by the user during insertion a new complaint will not be created.When inserting a 0.038" guidewire it could be confirmed that there was blockage.When continuing to push the guidewire through, a solid unknown plug appeared to be the cause of he blockage.The plug continued to flake and cause the same black flaking that was noted in the ziploc bag.The plug could not be identified with anything used at the biomerics fmi facility or from anything supplied with the stent for use.A potential root cause for this event could be, "part geometry".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: "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." "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 stent¿s 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." the actual/suspected device was inspected.

• Brand Name: BARD® INLAY® URETERAL STENT
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16014015
• Report Number: 1018233-2022-09694
• Device Sequence Number: 15288823
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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: 06/01/2026
• Device Model Number: 778624
• Device Catalogue Number: 778624
• Device Lot Number: NGGR0329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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