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

Catalog Number 787400

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2024

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 : device was not returned.

Event Description

It was reported that the patient experienced an adverse event directly attributable to the device 787400 - inlay optima multi-length ureteral stent with hydroglide guidewire, 4.7 fr., 22 ¿ 32cm and the patient experienced ureteral reflux, pain/discomfort and hematuria.This did not result in the patient injury requiring medical or surgical intervention.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT WITH GUIDEWIRE
• 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: 19010804
• MDR Text Key: 338997089
• Report Number: 1018233-2024-01721
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015318
• UDI-Public: (01)10801741015318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

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 Number: 787400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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