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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
Catalog Number 788426
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Irritability (2421)
Event Date 11/14/2023
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.
 
Event Description
It was reported that the product was used to eliminate obstruction within the ureter caused by a variety of benign, malignant, and post-traumatic conditions.The guidewire is used to provide transurethral and/or percutaneous access to the bladder, ureter, or renal pelvis.The basis for use was ureteral mucosal edema after ureteroscopic lithotripsy.The stent was left in the renal pelvis, ureter and bladder, and symptoms of bladder irritation occurred.The doctors treated spasms and remove the ureteral stent.Adverse events were bladder irritation symptoms.The patient needed antispasmodic treatment, time to remove the stent and take treatment measures.Treatment measures taken were antispasmodic treatment, time to remove the ureteral stent and adverse events improved.
 
Event Description
It was reported that the product was used to eliminate obstruction within the ureter caused by a variety of benign, malignant, and post-traumatic conditions.The guidewire is used to provide transurethral and/or percutaneous access to the bladder, ureter, or renal pelvis.The basis for use was ureteral mucosal edema after ureteroscopic lithotripsy.The stent was left in the renal pelvis, ureter and bladder, and symptoms of bladder irritation occurred.The doctors treated spasms and remove the ureteral stent.Adverse events were bladder irritation symptoms.The patient needed antispasmodic treatment, time to remove the stent and take treatment measures.Treatment measures taken were antispasmodic treatment, time to remove the ureteral stent and adverse events improved.
 
Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: "precautions: for single use only.Do not resterilize.Do not use if the package or product is damaged.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.Suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients.Exercise care.Tearing of the stent can be caused by sharp instruments.Ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure.Multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal." 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.H3 other text: the device was not returned.
 
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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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18300640
MDR Text Key330163675
Report Number1018233-2023-08852
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741015687
UDI-Public(01)00801741015687
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/16/2024
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 Catalogue Number788426
Device Lot NumberNGGX4990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/11/2023
Supplement Dates Manufacturer Received01/17/2024
Supplement Dates FDA Received01/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2022
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) Required Intervention;
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