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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 788624
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2023
Event Type  malfunction  
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.
 
Event Description
It was reported that the factory fault for the stent being blocked.They stated it was a factory fault and somehow the stent was blocked.It was stated that more information was required from the doctor.As per the follow up information received on 01nov2023, the event happened on the 23rd of october 2023.The stent could not feed into the guidewire.It was the bard nitinol guidewire and the stent could not feed over it, as if it was stuck.It was a once off event.
 
Event Description
It was reported that the factory fault for the stent being blocked.They stated it was a factory fault and somehow the stent was blocked.It was stated that more information was required from the doctor.As per the follow up information received on 01nov2023, the event happened on the 23rd of october 2023.The stent could not feed into the guidewire.It was the bard nitinol guidewire and the stent could not feed over it, as if it was stuck.It was a once off event.
 
Manufacturer Narrative
The reported event is unconfirmed as no blockage was present in the stent.Visual requirements states to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.Guidewire passage is to be performed with 0.038" guidewire.When evaluating the sample, it could be seen that the sample was removed from all original packaging.There were no visual defects that could be evaluated.A 0.038" guidewire passed through the sample with no hesitation.At the time of the evaluation of the stent the guidewire that was performed while using the stent was not provided for evaluation.The guidewire used by the user was received on 12mar2024.The guidewire was provided in a large ziploc bag.The guidewire passed through the returned stent with no hesitation.Dimensional evaluation noted the guidewire was measured at 0.03240" using a thickness gauge.Photo sample evaluation noted received 2 photo samples.First photo sample shows guidewire and stent within open packaging.Second photo sample zooms in on stent and guidewire on top of product packaging.Product packaging indicates material number, lot number, and expiration date.Therefore, the complaint report could not be confirmed.No root cause could be found because the reported event was unconfirmed.Dhr review is not required as the reported event is unconfirmed.Labelling review is not required as the reported event is unconfirmed.Correction: d 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 actual/suspected device was inspected.
 
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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 Key18150487
MDR Text Key328302364
Report Number1018233-2023-08200
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00801741015755
UDI-Public(01)00801741015755
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K043193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number788624
Device Lot NumberNGHN3374
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2023
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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