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

Model Number	788628
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the catheter was replaced in the patient.The external package of the new product was checked prior to use and found intact without any abnormalities.However once after the external package was opened, the pigtail coil at the tip of the ureteral stent was found to be broken.The user opened a new kit of stent to complete the procedure.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.No physical sample was returned, however, photo samples were submitted.The position of the stent pictured appears to be in a bent position; the sample does not appear to be broken by the position of the stent pictured.A potential root cause for this event could be, "inappropriate package design".As no patient involvement was reported the device was not used on a patient, though it is intended for treatment purposes.As the device was not returned for evaluation, it was unknown if it 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." 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.
Event or Problem Description
It was reported that on (b)(6) 2022, the catheter was replaced in the patient.The external package of the new product was checked prior to use and found intact without any abnormalities.However once after the external package was opened, the pigtail coil at the tip of the ureteral stent was found to be broken.The user opened a new kit of stent to complete the procedure.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13441221
• Report Number: 1018233-2022-00356
• Device Sequence Number: 19396040
• Product Code: FAD
• UDI-Device Identifier: 00801741015779
• UDI-Public: (01)00801741015779
• 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): 05/20/2022

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: 07/14/2025
• Device Model Number: 788628
• Device Catalogue Number: 788628
• Device Lot Number: NGFP3233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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