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

Model Number 787624

Device Problem Incorrect Measurement (1383)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

It was reported that the ureteral stent tip did not have a gradual narrowing, both the tip diameters are similar.When the user tried to identify the tip for stent insertion, it was noticed that both ends have a similar opening diameter.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event is inconclusive due to poor sample condition.No physical sample was returned, however, a photo sample was submitted; an evaluation of the photo sample was completed.No physical sample was provided to do a dimensional evaluation.The reported defect could not be evaluated based on the provided photo as it only shows the end of the tubing with no dimensions.A potential root cause for this event could be, "error of inspector".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.

Event Description

It was reported that the ureteral stent tip did not have a gradual narrowing, both the tip diameters are similar.When the user tried to identify the tip for stent for insertion, it was noticed that both ends have a similar opening diameter.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12882739
• MDR Text Key: 281545589
• Report Number: 1018233-2021-07553
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015431
• UDI-Public: (01)10801741015431
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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 Expiration Date: 05/08/2024
• Device Model Number: 787624
• Device Catalogue Number: 787624
• Device Lot Number: NGEP0842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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