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 07/26/2023

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 after unpacking, when removing the ureteral stent from the pigtail modulator, the stent ruptured.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation noted visual requirements state to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.When evaluating the sample, the separation could be located at the proximal pigtail.No stretching or discoloration was evaluated to the sample.Dimensional evaluation noted dimensional requirements state the od is to be at 0.079" ± 0.002", the tip id to be 0.043" ± 0.002", the guidewire to be 0.038" ± 0.001", and the tube to be 0.050" + 0.002" -0.001." the sample passed all dimensional requirements.The od measured at 0.0788" and 0.0791" 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 occurred was measured using a 0.050" pin gauge.Although an exact root cause could not be determined a potential root cause could be stent not stiff enough.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 Description

It was reported that after unpacking, when removing the ureteral stent from the pigtail modulator, the stent ruptured.

• 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: 17490415
• MDR Text Key: 321245342
• Report Number: 1018233-2023-05952
• 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: 11/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 788626
• Device Lot Number: NGGX4971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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