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

Model Number	778622
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
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.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.
Event or Problem Description
It was reported, that the pusher of the ureteral stent broke in use during procedure.This had happened 3 times.The pictures shows, the lead markings left behind in new repels, and where on the pusher the break happened.
Event or Problem Description
It was reported that the pusher of the ureteral stent broke in use during procedure.This had happened 3 times.The pictures shows the lead markings left behind in new repels and where on the pusher the break happened.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.Although an exact root cause could not be determined a potential root cause could be material selection.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "precautions: -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." 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.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.No physical sample was returned, however, photo samples were submitted.Gross visual evaluation noted evaluation of the first photo sample noted a portion broken off the push catheter.The second photo sample showed the tip of the stent separated from the body and visible within the patient's body on a scan.Although an exact root cause could not be determined a potential root cause could be user does not handle with care, bends sharply.The dhr review not required as no lot number was provided.The instructions for use were found adequate and states the following: precautions: 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.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 the pusher of the ureteral stent broke in use during procedure.This had happened 3 times.The pictures shows the lead markings left behind in new repels and where on the pusher the break happened.
Event or Problem Description
It was reported that the pusher of the ureteral stent broke in use during procedure.This had happened 3 times.The pictures shows the lead markings left behind in new repels and where on the pusher the break happened.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.No physical sample was returned, however, photo samples were submitted.Visual evaluation of the first photo sample noted a portion broken off the push catheter.The second photo sample shows the patient body on a scan however due to poor image quality further evaluation cannot be completed.Based on first photo sample received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be user does not handle with care, bends sharply.A dhr review not required as no lot number was provided.The instructions for use were found adequate and state the following: "precautions: -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." 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.

• Brand Name: BARD® INLAY® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16986388
• Report Number: 1018233-2023-03696
• Device Sequence Number: 17855775
• Product Code: FAD
• UDI-Device Identifier: 00801741014819
• UDI-Public: (01)00801741014819
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K983498
• 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,Followup
• Report Date (Section B): 01/10/2024

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 Model Number: 778622
• Device Catalogue Number: 778622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 09/27/2023; 12/21/2023; 01/10/2024
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/28/2023; 12/22/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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