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 Hematuria (2558)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred in april 2022.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 zanaty, f., elshazly, m., kandeel, h., & salman, b.(2023).A single center comparative study of two single use digital flexible ureteroscopy in the management of renal stones less than 2 cm.World journal of urology, 1(1), 6.Https://doi.Org/10.1007/s00345-023-04290-6.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 "a single center comparative study of two single use digital flexible ureteroscopy in the management of renal stones less than 2 cm" by fouad zanat, mohamed elshazly, kandeel hossam and salman baher.Per the article, between april 2022 and january 2023, there was one case of a patient that experienced post-operative hematuria (grade i).It was said that it was managed conservatively with fluids and hemostatic agents.There were no additional patient complications reported.

• 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: 18758726
• MDR Text Key: 336003673
• Report Number: 2124215-2024-07994
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/22/2024
• 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