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

Model Number	788614
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
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 patient underwent ureteroscopic surgery in the right side and needed to indwell a ureteral stent.The nurse disassembled a root and found that the tube was ruptured.Another stent was opened and that was also found to be ruptured.It was mentioned that extra operation or drug therapy was included for this incident.
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 patient underwent ureteroscopic surgery in the right side and needed to indwell a ureteral stent.The nurse disassembled a root and found that the tube was ruptured.Another stent was opened and that was also found to be ruptured.It was mentioned that extra operation or drug therapy was included for this incident.Per follow up information received via ibc on 19aug2022, it was stated that both stents belonged to the same lot and the event included extra operation or drug therapy was referring to the replacement of a new device.Per notification received from investigator on 21sep2022, it was stated that the customer returned two ureteral stents and both stents were broken.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.A photo sample was submitted showing two stents and one was observed to be broken into two pieced.The ureteral stent was returned without the original packaging.An evaluation of the physical sample was completed.It could be seen that a separation occurred on the body of the stent; the separation appears to be halfway through and and removed by pulling the stent apart.The tube was noted to be indented on one side of the separation and the material was stretched and discolored on the other side.The sample passed all dimensional requirements; the tip inner diameter measured 0.043" with a pin gauge, the tube inner diameter measured 0.050" with a pin gauge, a 0.038" guidewire passed through both parts of the sample with no resistance.Unable to determine a specific cause, however, based on the risk document a potential root cause could be, "material selection".The device was used for treatment purposes.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: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation." "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." 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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the patient underwent ureteroscopic surgery in the right side and needed to indwell a ureteral stent.The nurse disassembled a root and found that the tube was ruptured.Another stent was opened and that was also found to be ruptured.It was mentioned that extra operation or drug therapy was included for this incident.Per follow up information received via ibc on 19aug2022, it was stated that both stents belonged to the same lot and the event included extra operation or drug therapy was referring to the replacement of a new device.Per notification received from investigator on 21sep2022, it was stated that the customer returned two ureteral stents and both stents were broken.

• Brand Name: BARD® INLAY OPTIMA® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15258773
• Report Number: 1018233-2022-06574
• Device Sequence Number: 6720550
• Product Code: FAD
• UDI-Device Identifier: 00801741015724
• UDI-Public: (01)00801741015724
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Model Number: 788614
• Device Catalogue Number: 788614
• Device Lot Number: NGGQ0323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 02/03/2023
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 10/03/2022; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 52 KG