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

Catalog Number 788624

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the user found tear on the stent tip during preparation.

Event Description

It was reported that the user found tear on the stent tip during preparation.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection found a tear on the end of the stent.How and when the problem occurred could not be determined.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: ¿method for use 1.(1) do not forcibly insert or remove the stent.It may injured patient or/and damage this product.(2) avoid improper handling of stent such as bending, kinking, tearing and etc.(3) avoid contact with sharp edges as this may cause damage to the stent.If grasping device is used, the stent should be removed from ureter first.Tearing of the stent can be caused by sharp instrument.(4) determine the proper stent length for the patient.Selection of too short a stent may result in migration.(5) in the event of stent migration , cystoscopy or ureteroscopy should be used to return the stent to the original position or removed it from the patient.(6) care should be exercise d when removing the stent to eliminate tearing or fragmentation.".

• 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 GA 30014
• MDR Report Key: 8200494
• MDR Text Key: 131532795
• Report Number: 1018233-2018-06205
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: 08/01/2021
• Device Catalogue Number: 788624
• Device Lot Number: MYCVTE12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1