MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 06/01/2012

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred from june 2012 to march 2021.Block d4: the suspected device upn and lot number could not be provided.The exact device expiration date is unknown; however, it was reported that the device was not expired.Block g2: literature source unno, r., hosier, g., hamouche, f., bayne, d.B., stoller, m.L., & chi, t.(2022).Single-use ureteroscopes are associated with decreased risk of urinary tract infection after ureteroscopy for urolithiasis compared to reusable ureteroscopes.Journal of endourology, 37 (0).Doi: 10.1089/end.2022.0480.Block h6: imdrf patient code e1310 is being used to capture the reportable issue of urinary tract infection.

Event Description

Boston scientific became aware of an event involving a lithovue flexscope through the article, single-use ureteroscopes are associated with decreased risk of urinary tract infection after ureteroscopy for urolithiasis compared to reusable ureteroscopes, by rei unno, et al.Per the article, between june 2012 to march 2021, single-use ureteroscopes were associated with a twofold decreased risk of uti after ureteroscopy for urolithiasis compared to reusable ureteroscopes.In addition, their use was associated with increased subjective stone clearance rates and fewer postoperative patient phone calls.These results suggest that utilizing single-use ureteroscopes may be one method to decrease infectious complications after stone surgery, although improving clinical outcomes and lowering health care service utilization.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18768117
• MDR Text Key: 336117970
• Report Number: 2124215-2024-09306
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• 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): Required Intervention