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

Model Number	787624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ureteral stent was found broken at the loop and the event occurred prior to use on patient.The customer opened another package for use.
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 ureteral stent was found broken at the loop and the event occurred prior to use on the patient.The customer opened another package for use.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.The ureteral stent was returned with the opened original packaging.Photo samples were submitted showing one end of the pigtail completely broken off the body of the stent.Visual evaluation of the physical sample noted the separation occurred at the proximal end of the stent; the separation looks similar to what is seen when the material is cut with a sharp object due to the indentation of the material forming inward.The suture porthole also appeared to have a slight separation, which is seen when the suture is pulled away from the stent.The suture was not provided for evaluation.The stent met dimensional requirements, the tip and tube inner diameter were measured with a pin gauge and found to be 0.043" and 0.050", respectively, the outer diameter measured at 0.0803" and 0.0804" using a laser micrometer.A 0.038" guidewire successfully passed through both parts of the sample without resistance.Although a specific cause could not be determined, based on the evaluation results a potential root cause could be rough handling by the user.As no patient involvement was reported the device was not used, though it is intended 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: "suture may be cut off prior to stent placement." "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." 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 actual/suspected device was inspected.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ 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: 15650753
• Report Number: 1018233-2022-08067
• Device Sequence Number: 5966654
• Product Code: FAD
• UDI-Device Identifier: 10801741015431
• UDI-Public: (01)10801741015431
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K043193
• 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,Followup
• Report Date (Section B): 02/23/2023

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: 06/29/2026
• Device Model Number: 787624
• Device Catalogue Number: 787624
• Device Lot Number: NGGQ1788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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