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

Model Number	786400
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
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 the distal end of the ureteral stent broke off in the kidney which increased the surgery time because it was necessary to go and retrieved the small piece of catheter.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.The ureteral stent was returned with the opened original packaging.The tip of the stent was observed to be broken off, however, the broken tip was not returned for evaluation.No foreign matter or residue was present on the outside of the device or within the device when a guidewire was inserted.Though the event mentions the stent was broken off in the kidney, the evaluation shows the break was close in appearance to when the material is ripped apart.The material of the tip was observed to be discolored and stretched leaving the separation jagged and the material thin.The outer diameter of the device was measured with a laser micrometer and found to be 0.0622" and the tube inner diameter measured 0.040" with a pin gauge; both measurements were within specifications.A 0.035" guidewire was able to pass through the sample without resistance.The specific cause for this event could not be found, however, based on the risk management file a potential root cause could be, "material selection".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 insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." the information provided by bd 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 bd.
Event or Problem Description
It was reported that the distal end of the ureteral stent broke off in the kidney which increased the surgery time because it was necessary to go and retrieved the small piece of catheter.
Event or Problem Description
It was reported that the distal end of the ureteral stent broke off in the kidney which increased the surgery time because it was necessary to go and retrieved the small piece of catheter.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent was returned with the opened original packaging.The tip of the stent was observed to be broken off, however, the broken tip was not returned for evaluation.No foreign matter or residue was present on the outside of the device or within the device when a guidewire was inserted.Though the event mentions the stent was broken off in the kidney, the evaluation shows the break was close in appearance to when the material is ripped apart.The material of the tip was observed to be discolored and stretched leaving the separation jagged and the material thin.The outer diameter of the device was measured with a laser micrometer and found to be 0.0622" and the tube inner diameter measured 0.040" with a pin gauge; both measurements were within specifications.A 0.035" guidewire was able to pass through the sample without resistance.The specific cause for this event could not be found, however, based on the risk management file a potential root cause could be, "material selection".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 insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." corrections: b.H11:section a through f - the information provided by bd 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 bd.The actual/suspected device was inspected.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH NICORE¿ GUIDEWIRE
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15096289
• Report Number: 1018233-2022-05735
• Device Sequence Number: 5119900
• Product Code: FAD
• UDI-Device Identifier: 10801741014991
• UDI-Public: (01)10801741014991
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 786400
• Device Catalogue Number: 786400
• Device Lot Number: NGDN1549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 10/28/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/20/2022; 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2019
• 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: Required Intervention
• Patient Sex: Unknown