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

Model Number	786426
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event is unconfirmed as the problem could bit be reproduced.No visual defects were noted, however, the sample was noted to be used due to residue (red foreign matter) that was extracted when the guidewire was removed.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.The actual/suspected device was inspected.
Event or Problem Description
It was reported that there were 3 ureteral stents had the same issue in the same operation.After opening the package, the stent could not be advanced.It was mentioned that there were no other complications.As per follow up information received via ibc on (b)(6) 2022, it was stated that all three stents were belonging to the same lot.As per notification received from investigator on (b)(6) 2023, it was stated that the user returned three used samples.It was stated that when the samples were evaluated by the supplier, they were confirmed to have been used.It was also stated that one of the stents was observed to be broken.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• 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: 16635217
• Report Number: 1018233-2023-02101
• Device Sequence Number: 17673854
• Product Code: FAD
• UDI-Device Identifier: 10801741015042
• UDI-Public: (01)10801741015042
• 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
• Report Date (Section B): 03/13/2023

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: 09/24/2024
• Device Model Number: 786426
• Device Catalogue Number: 786426
• Device Lot Number: NGFV4250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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