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

Catalog Number 788626

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

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 Description

It was reported that when the doctor was about to place the ureteral stent in the patient and opened the stent package, they found that the stent had been broken.Then they replaced the broken stent with a new one and completed the operation.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual requirements state to use unaided eye at 12" to 18" distance under room lighting unless otherwise noted.Dimensional requirements state the od to be 0.079" ± 0.002", tip id to be 0.043" ± 0.002, guidewire to be 0.038" ± 0.002", and tube id to be 0.050" + 0.002" -0.001".When evaluating the sample, it could be seen that the separation took place on the body of the stent.The separation looks similar to what is seen when the material is cut due to the indented inward of the material with no stretching stretching or discoloration to the material.There was also an additional mark close to the separation.The suture porthole was separated to the end of the stent.This is seen when the suture is pulled from the stent.The suture does appear to be damaged and formed as if it had been kinked due to being pulled from the stent.Dimensional evaluation noted the sample passed all dimensional requirements.The od measured at 0.797" and 0.0803" using a laser micrometer.The tip id was measured using a 0.043" pin gauge.A 0.038" guidewire passed through the sample with no hesitation.The tube id where the separation took place was measured using a 0.050" pin gauge.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be inappropriate package design.However, there was insufficient information to confirm this potential root cause.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." correction: d 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 Description

It was reported that when the doctor was about to place the ureteral stent in the patient and opened the stent package, they found that the stent had been broken.Then they replaced the broken stent with a new one and completed the operation.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Type of Device: 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: 18247275
• MDR Text Key: 329666829
• Report Number: 1018233-2023-08682
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015762
• UDI-Public: (01)00801741015762
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 788626
• Device Lot Number: NGGZ2759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other