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

Model Number	787426
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
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 when opening the package, the two pigtail rings of the ureteral stent were found to be ruptured.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.A photo sample was submitted which showed the stent broken into two pieces.Visual evaluation noted the sample was separated on the body of the stent, the separation appeared to be cut as the material did not appear to be stretched or discolored.The suture was threaded through the entire body of the stent and the portholes.Although a specific root cause cannot be determined, based on the risk document a potential root cause for this event could be, "inappropriate package design".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and states the following: the inlay optima ureteral stent instructions for use, baw7659454 revision 0, was reviewed and found to be adequate as it states: "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 actual/suspected device was inspected.
Event or Problem Description
It was reported that when opening the package, the two pigtail rings of the ureteral stent were found to be ruptured.

• 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: 15447360
• Report Number: 1018233-2022-07254
• Device Sequence Number: 12638089
• Product Code: FAD
• UDI-Device Identifier: 10801741015363
• UDI-Public: (01)10801741015363
• 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): 02/10/2023

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: 04/28/2026
• Device Model Number: 787426
• Device Catalogue Number: 787426
• Device Lot Number: NGGN1705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 02/11/2023
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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