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

Model Number	787624
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
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 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.
Event or Problem Description
It was reported that at the moment of opening the package it was detected that a part of the ureteral stent was fragmented.It was later reported per additional information received from the ibc via email on (b)(6) 2019; customer says the brake was in the distal end of the stent.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.Evaluation report of the returned sample, submitted by futurematrix interventional, stated that the bladder end pigtail was detached from the body of the stent.The report also stated that there were currently three 100% inspections in place to check for noted issues.End user was considered to be a potential root cause.This cannot be ruled out due to uncertainty of force used to manipulate the stent during further packaging after leaving futurematrix facility or when removing the stent from the final packaging.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: ¿urethral stents should be checked periodically for signs of encrustation and proper function." 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.
Event or Problem Description
It was reported that at the moment of opening the package it was detected that a part of the ureteral stent was fragmented.It was later reported per additional information received from the ibc via email on 27may2019; customer says the brake was in the distal end of the stent.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: URETERAL STENT W HYDROGLIDE GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8669281
• Report Number: 1018233-2019-02922
• Device Sequence Number: 2494943
• Product Code: FAD
• UDI-Device Identifier: 10801741015431
• UDI-Public: (01)10801741015431
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/29/2019

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: 07/28/2023
• Device Model Number: 787624
• Device Catalogue Number: 787624
• Device Lot Number: NGCX3250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening