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

Model Number	778726
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that during the procedure, the stent broke off at the end.There was no reported impact to the procedure or patient.
Event or Problem Description
It was reported that during the procedure, the stent broke off at the end.There was no reported impact to the procedure or patient.
Additional Manufacturer Narrative
Received 1 ureteral stent sheath only in open packaging.The reported event was unconfirmed since the stent was not returned with the sample (incomplete device return).During the visual inspection no obvious defects were noted in the sample.The stent was not evaluated visually and dimensionally because it was not received with the sample.The push catheter dimensions were found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "¿ improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.¿ exercise care.Tearing of the stent can be caused by sharp instruments.¿ care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation.Section" (b)(4).

• Brand Name: BARD® INLAY® URETERAL STENT
• Common Device Name: BARD URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7045026
• Report Number: 1018233-2017-05998
• Device Sequence Number: 1079587
• Product Code: FAD
• UDI-Device Identifier: 00801741014901
• UDI-Public: (01)00801741014901
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 10/11/2018
• Device Model Number: 778726
• Device Catalogue Number: 778726
• Device Lot Number: NGYC2721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1