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

Catalog Number 787626

Device Problems Difficult to Insert (1316); Device Damaged Prior to Use (2284)

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

Event Date 11/14/2018

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 when the string that was attached to the stent was pulled, the operator confirmed that the distal end part of the stent was narrow.This caused the guide wire not to pass through the stent.Allegedly, the operator thought that there was a possibility that when they pulled the string, it got entangled in the stent and caused the stent to have become narrow at the end.

Event Description

It was reported that when the string that was attached to the stent was pulled, the operator confirmed that the distal end part of the stent was narrow.This caused the guide wire not to pass through the stent.Allegedly, the operator thought that there was a possibility that when they pulled the string, it got entangled in the stent and caused the stent to have become narrow at the end.

Manufacturer Narrative

The reported event was confirmed as use related.The evaluation concluded that the stent was narrowed at the end.The user confirmed that there was a possibility that when he/she pulled the string, it became entangled in the stent causing the stent to narrow at the end - user related.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: ¿(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.Misuse could damage the overall integrity of the stent.(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 body.(6) care should be exercised when removing the stent to eliminate tearing or fragmentation." section a through f - the information provided by bd represents all of 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.

• 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 GA 30014
• MDR Report Key: 8134486
• MDR Text Key: 129756508
• Report Number: 1018233-2018-05847
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 787626
• Device Lot Number: MYCPTA54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1