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	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
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 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 the quality department reported failure of ureteral stent during the left endoscopic ureterolithotomy procedure.When entering the double j catheter and positioning it on the guide, it was evident that it could not be advanced despite having the equipment and the guide in the proper position.It was observed that the distal end folds back on itself in the form of an accordion.When extracting the catheter, it shows deterioration and angulation of the same.Despite multiple attempts, it was not possible to advance the catheter, so the ordering of the procedure requests another element of the same brand and reference, noting that it works correctly and did not present complications.For this reason, the customer requested to review the item under warranty control.
Additional Manufacturer Narrative
The reported event is unconfirmed as the failure could not be reproduced.The ureteral stent was returned with the original packaging.Photo samples of the stent within the packaging were provided and no abnormalities were noted.No visible defects were noted on the returned sample.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.As the reported event is unconfirmed, a labeling review is not required.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.
Event or Problem Description
It was reported that the quality department reported failure of ureteral stent during the left endoscopic ureterolithotomy procedure.When entering the double j catheter and positioning it on the guide, it was evident that it could not be advanced despite having the equipment and the guide in the proper position.It was observed that the distal end folds back on itself in the form of an accordion.When extracting the catheter, it shows deterioration and angulation of the same.Despite multiple attempts, it was not possible to advance the catheter, so the ordering of the procedure requests another element of the same brand and reference, noting that it works correctly and did not present complications.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ 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: 15986305
• Report Number: 1018233-2022-09531
• Device Sequence Number: 6103862
• Product Code: FAD
• UDI-Device Identifier: 10801741015431
• UDI-Public: (01)10801741015431
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: NGFZ2772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2022
• 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