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

Model Number 788426

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

It was reported that the user felt catheter were in weird curved line.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was unconfirmed as the problem could not be reproduced.The ureteral stent was returned in the opened original packaging.The only curves that could be seen are the two pigtails that are formed and the expected curve from the way the stents are packaged and shipped.No defects could be confirmed.The sample passed all dimensional requirements; the outer diameter measured 0.0612" with a laser micrometer, the tip inner diameter measured 0.039" with a pin gauge, the overall length measured 259mm, the proximal pigtail outer diameter measured 0.5760", and the distal pigtail outer diameter measured 0.5845".A 0.035" guidewire successfully passed through the sample with no resistance.As no patient involvement was reported the device was not used, however, is intended for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed, a label/packaging review is not required.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 the user felt the catheter were in a weird curved line.

• 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: 16527203
• MDR Text Key: 311231214
• Report Number: 1018233-2023-01662
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015687
• UDI-Public: (01)00801741015687
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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 Model Number: 788426
• Device Catalogue Number: 788426
• Device Lot Number: NGGQ4267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/12/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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