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

Model Number	788628
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
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 ureteral stent was broken during the procedure.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation of the returned stent noted visual requirements state to use unaided eye at 12" to 18" distance under normal room light unless otherwise noted.When evaluating the sample, it could be seen that the separation took place at the distal pigtail.The separation is at an angle with no discoloration or stretching of the material.The suture and pigtail straightener were not provided for evaluation.No other defects were evaluation.Dimensional evaluation of the returned stent noted dimensional requirements state the od is to be 0.079" ± 0.002", tip id 0.043" ± 0.002", guidewire to be 0.038" ± 0.001", and tube id to be 0.050" + 0.002" -0.001".The sample passed dimensional requirements.The od was measured at 0.0794" and 0.0780" using a laser micrometer.The tip id was a 0.043" pin gauge.A 0.038" guidewire passed through the sample with no hesitation.The tube id where the separation occurred was measured using a 0.050" pin gauge.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 did not show any problems or conditions that would have 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 inner polybag so as not to cause 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." 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 ureteral stent was broken during the procedure.Per follow-up information received from ibc on 23jun2023, stated that the device was not used with the patient, so no injury.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.When evaluating the sample, it could be seen that the separation took place at the distal pigtail.The separation is at an angle with no discoloration or stretching of the material.The suture and pigtail straightener provided for evaluation.No other defects were evaluation.Although an exact root cause could not be determined 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 inner polybag so as not to cause 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." 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 ureteral stent was broken during the procedure.Per follow-up information received from ibc on 23jun2023, stated that the device was not used with the patient, so no injury.
Event or Problem Description
It was reported that the ureteral stent was broken during the procedure.Per follow-up information received from ibc on 23jun2023, stated that the device was not used with the patient, so no injury.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted visual requirements per cs-7090-xx state to use unaided eye at 12" to 18" distance under normal room light unless otherwise noted.When evaluating the sample, it could be seen that the separation took place at the distal pigtail.The separation is at an angle with no discoloration or stretching of the material.The suture and pigtail straightener provided for evaluation.No other defects were evaluation.Dimensional evaluation noted dimensional requirements per cd-7090-xx state the od is to be 0.079" ± 0.002", tip id 0.043" ± 0.002", guidewire to be 0.038" ± 0.001", and tube id to be 0.050" + 0.002" -0.001".The sample passed dimensional requirements per cd-7090-xx.The od was measured at 0.0794" and 0.0780" using a laser micrometer.The tip id was a 0.043" pin gauge.A 0.038" guidewire passed through the sample with no hesitation.The tube id where the separation occurred was measured using a 0.050" pin gauge.Although an exact root cause could not be determined 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 inner polybag so as not to cause 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." 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.When evaluating the sample, it could be seen that the separation took place at the distal pigtail.The separation is at an angle with no discoloration or stretching of the material.The suture and pigtail straightener provided for evaluation.No other defects were evaluation.Although an exact root cause could not be determined 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 inner polybag so as not to cause 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: 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 ureteral stent was broken during the procedure.Per follow-up information received from ibc on 23jun2023, stated that the device was not used with the patient, so no injury.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17237768
• Report Number: 1018233-2023-04803
• Device Sequence Number: 7076396
• Product Code: FAD
• UDI-Device Identifier: 00801741015779
• UDI-Public: (01)00801741015779
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/11/2024

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 Expiration Date: 06/29/2026
• Device Model Number: 788628
• Device Catalogue Number: 788628
• Device Lot Number: NGGU1564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 09/30/2023; 10/12/2023; 12/12/2023; 01/11/2024
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 10/03/2023; 10/17/2023; 12/13/2023; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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