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

Model Number	786624
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
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.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.
Event or Problem Description
It was reported that one drainage hole in the ureteral stent was found to be bent upon opening of the package.It was impossible to insert the guidewire after multiple attempts and the guidewire could not be passed through.Per follow up information received via ibc on (b)(6) 2022, it was stated that the ureteral stent was not used on the patient.
Event or Problem Description
It was reported that one drainage hole in the ureteral stent was found to be bent upon opening of the package.It was impossible to insert the guidewire after multiple attempts and the guidewire could not be passed through.Per follow up information received via ibc on 05aug2022, it was stated that the ureteral stent was not used on the patient.
Additional Manufacturer Narrative
The reported event is unconfirmed, as the problem could no be reproduced.Photo samples were submitted, however, no deformation could be seen from the photos.The ureteral stent and push catheter were returned with the original packaging.When visually inspecting the sample at 12" to 18" distance under normal room lighting no visual defects were noted, however, it did appear that the sample had been used due to the build up in the portholes.The correct number of portholes were noted to be present and no deformation of the portholes was noted.The device was attempted to be used for treatment purposes.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a label/packaging review is not required.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15190802
• Report Number: 1018233-2022-06177
• Device Sequence Number: 17605144
• Product Code: FAD
• UDI-Device Identifier: 10801741015110
• UDI-Public: (01)10801741015110
• 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
• Report Date (Section B): 12/09/2022

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: 05/22/2024
• Device Model Number: 786624
• Device Catalogue Number: 786624
• Device Lot Number: NGEX2467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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