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

Model Number	787426
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that during the ureteroscopy, the opening of the retention tube was broken.
Event or Problem Description
It was reported that during the ureteroscopy, the opening of the retention tube was broken.
Additional Manufacturer Narrative
The reported event was confirmed.The sample was received in good condition, opened and without original packaging.Visual inspection noted the stent suture was not attached to the stent, and the pigtail from the bladder end was detached at the porthole.The device was not returned with the pigtail straightener or pusher.The pusher had a slight bend and a kink along the shaft.The device was viewed under 25x magnification.No deformities were noted other than the break on the bladder end of the pigtail at the midpoint of the porthole.The material of the stent at the break location showed no signs of damage or weakness.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: ¿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 the inner polybag to eliminate tearing or fragmentation." correction: d10, h3.H11: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
• Common Device Name: STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8052094
• Report Number: 1018233-2018-05261
• Device Sequence Number: 19229075
• Product Code: FAD
• UDI-Device Identifier: 10801741015363
• UDI-Public: (01)10801741015363
• Combination Product (Y/N): N
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 787426
• Device Catalogue Number: 787426
• Device Lot Number: NGBS0061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1