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

Model Number 778624

Device Problems Incorrect Measurement (1383); Biocompatibility (2886)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11141002
• MDR Text Key: 225804217
• Report Number: 1018233-2020-22409
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 778624
• Device Catalogue Number: 778624
• Device Lot Number: NGEV1808
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention