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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT Back to Search Results
Model Number 788824
Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)
Patient Problems Hemorrhage/Bleeding (1888); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that the patient experienced stone formation and stent encrustation, edema, ureteral reflux, hemorrhage, infection, pain and discomfort while using the bard ureteral stent.Medical intervention was unknown.
 
Manufacturer Narrative
The reported event is inconclusive because no sample was returned.Potential root causes for this event could be, "material selection" or "part geometry".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislodgement, fragmentation, migration, occlusion ¿ fistula formation ¿ loss of renal function ¿ hemorrhage ¿ pain/discomfort ¿ stent encrustation ¿ hydronephrosis ¿ perforation of kidney, renal pelvis, ureter and/or bladder ¿ ureteral erosion ¿ infection ¿ urinary symptoms" "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort." h11: section a through f - the information provided by bd represents all 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 Description
It was reported that the patient experienced stone formation and stent encrustation, edema, ureteral reflux, hemorrhage, infection, pain and discomfort while using the bard ureteral stent.Medical intervention was unknown.
 
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Brand Name
BARD® INLAY OPTIMA® URETERAL STENT
Type of Device
URETERAL STENT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13314061
MDR Text Key284172274
Report Number1018233-2022-00145
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741015915
UDI-Public(01)00801741015915
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/26/2022
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? No
Device Operator Health Professional
Device Model Number788824
Device Catalogue Number788824
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2021
Initial Date FDA Received01/21/2022
Supplement Dates Manufacturer Received04/26/2022
Supplement Dates FDA Received05/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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