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

Model Number 788626

Device Problem Partial Blockage (1065)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It was reported that the stent got blocked a period of time after placement.Hydronephrosis and calculi occurred.It was unknown what medical intervention was provided for the infection.Per additional information via email from ibc on (b)(6) 2023, ureteral stent was placed to operate kidney stones, hydronephrosis and stones appear after the stent was placed for three months, stent removal process did not cause harm to the patient.Smastan(b)(6)2023.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported event is unconfirmed as the reported failure could not be reproduced.A photo sample was submitted, however, could not be evaluated for the reported event.The ureteral stent was returned without the original packaging.An evaluation of the physical sample was completed by future matrix on 14jun2023.No visual non-conformances were noted on the returned sample.The sample passed all dimensional requirements per cd-7090-xx; the outer diameter measured at 0.0794" using a laser micrometer, the tip inner diameter measured 0.043" with a pin gauge.A 0.038" guidewire passed through the sample with no resistance.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.As the reported event is unconfirmed, a label/packaging review is not required.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.

Event Description

It was reported that the stent got blocked a period of time after placement.Hydronephrosis and calculi occurred.It was unknown what medical intervention was provided for the infection.Per additional information via email from ibc on 28apr2023, ureteral stent was placed to operate kidney stones, hydronephrosis and stones appear after the stent was placed for three months, stent removal process did not cause harm to the patient.

• 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 Key: 16945988
• MDR Text Key: 315380507
• Report Number: 1018233-2023-03497
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015762
• UDI-Public: (01)00801741015762
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 788626
• Device Catalogue Number: 788626
• Device Lot Number: NGFU5214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other