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

Model Number 787626

Device Problem Biocompatibility (2886)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the ureteral stent was found to be full of calculi in the bladder, accompanied by bloodshot.It was pulled out and found that the kidney end was also full of stones.

Event Description

It was reported that the ureteral stent was found to be full of calculi in the bladder, accompanied by bloodshot.It was pulled out and found that the kidney end was also full of stones.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "package contains leachable that get on product".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11294061
• MDR Text Key: 230741359
• Report Number: 1018233-2021-00327
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015448
• UDI-Public: (01)10801741015448
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/09/2021

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 Expiration Date: 08/18/2022
• Device Model Number: 787626
• Device Catalogue Number: 787626
• Device Lot Number: NGCS3739
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 05/09/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention