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

Model Number	778624
Medical Device Problem Codes	Incorrect Measurement (1383); Biocompatibility (2886)
Health Effect - Clinical Codes	No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
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 the string of urethral stent seemed to be bit thicker than normal and it did not move very well through the cystoscope.While the surgeon was attempting to place it, the string tugged and tangled.So, the entire stent had to be removed.Hence, the string could be cut off and the stent could be replaced.Per follow up response received via mail on 22dec2020, the stent was removed and the string had to be cut, which resulted in an additional procedure for the patient to have it removed.
Event or Problem Description
It was reported that the string of the ureteral stent seemed to be bit thicker than normal and it did not move very well through the cystoscope.While the surgeon was attempting to place it, the string tugged and tangled so the entire stent was removed.Hence the string could be cut off and the stent could be replaced.Per follow up response received via email on 22dec2020 the stent was removed and the string had to be cut which resulted in an additional procedure for the patient to have it removed.
Additional Manufacturer Narrative
Upon further review it has been determined the information in this record is of a duplicate record already submitted to the fda, therefore bard/bd has determined that this mdr is not reportable.

• Brand Name: BARD INLAY URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11141002
• Report Number: 1018233-2020-22409
• Device Sequence Number: 19757442
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2025
• Device Model Number: 778624
• Device Catalogue Number: 778624
• Device Lot Number: NGEV1808
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: Required Intervention