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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT Back to Search Results
Model Number 778626
Device Problem Calcified (1077)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 01/18/2022
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2022, the patient was performed with minimally invasive percutaneous renal lithotripsy and lithotripsy with the f6 double j tube was indwelled as an internal ureteral stent.When the stent was taken out, a stone was formed on the wall of the stent, and the patient felt pain and discomfort.It was also stated that the inner stent coating was necessary since the patient was prone to calculi.The doctor instructed the patient to drink plenty of water and gave symptomatic and supportive treatment.No medical intervention was reported.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation.A potential root cause for this event could be, "material selection".The device was used for treatment purposes, however, it is unknown if it had met relevant specifications or contributed to the reported event.No manufacturing issues or non-conformances were noted in the dhr review that could have caused or contributed to the reported event.Based on the results of the investigation no additional action is required at this time.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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 device was not returned.
 
Event Description
It was reported that on (b)(6) 2022, the patient was performed with minimally invasive percutaneous renal lithotripsy and lithotripsy with the f6 double j tube was indwelled as an internal ureteral stent.When the stent was taken out, a stone was formed on the wall of the stent, and the patient felt pain and discomfort.It was also stated that the inner stent coating was necessary since the patient was prone to calculi.The doctor instructed the patient to drink plenty of water and gave symptomatic and supportive treatment.No medical intervention was reported.
 
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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
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 Key13932377
MDR Text Key288124935
Report Number1018233-2022-01672
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741014833
UDI-Public(01)00801741014833
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K983498
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number778626
Device Catalogue Number778626
Device Lot NumberNGFT5440
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2021
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;
Patient Age50 YR
Patient SexMale
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