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

Model Number	786726
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
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 patient underwent the right flexible ureteroscope and required to have a ureteral stent.Upon opening of the package of one such stent, the nurse found that it was ruptured.The catheter was reinserted to cope with the injury to the ureter caused by catheter removal.No medical intervention was reported.Per follow up information received on 19-sep-2022, product was not used on the patient so no injury.
Event or Problem Description
It was reported that patient underwent the right flexible ureteroscope and required to have a ureteral stent.Upon opening of the package of one such stent, the nurse found that it was ruptured.The catheter was reinserted to cope with the injury to the ureter caused by catheter removal.No medical intervention was reported.Per follow up information received on 19-sep-2022, product was not used on the patient so no injury.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The physical sample was not returned, however, a photo sample was submitted.Visual evaluation noted one end of the pigtail was completely broken off the body of the stent.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "inappropriate package design".As no patient involvement was reported and the device was not used, however, it is intended for treatment purposes.It is unknown if the device had met all relevant specifications.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 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.Actual/suspected device was evaluated.

• 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: 15477226
• Report Number: 1018233-2022-07421
• Device Sequence Number: 12223657
• Product Code: FAD
• UDI-Device Identifier: 10801741015202
• UDI-Public: (01)10801741015202
• 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): 02/15/2023

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: 04/16/2024
• Device Model Number: 786726
• Device Catalogue Number: 786726
• Device Lot Number: NGFS3239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2021
• 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