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 Problems Fever (1858); Urinary Tract Infection (2120)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred from june 2020 to jun 2021.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.Imdrf patient code e1310 is being used to capture the reportable issue of urinary tract infection.

Event Description

Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report# and manufacturer report# 2124215-2024-07994 for the other associated device information.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 zanaty, et al.Per the article, between (b)(6) 2020 to (b)(6) 2021, there were six cases suffered from post-operative fever (grade ii) due to urinary tract infection (uti), five cases of them in pusen group versus one case in lithovue group.All cases managed conservatively by fluids, antibiotics and antipyretics with no serious outcomes.Postoperative hematuria (grade i) were found in four cases, three cases in pusen group and one case in lithovue group.It was managed conservatively with fluids and hemostatic agents.

Event Description

Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report# 2124215-2024-07992 and manufacturer report# 2124215-2024-07994 for the other associated device information.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 zanaty, et al.Per the article, between june 2020 to june 2021, there were six cases suffered from post-operative fever (grade ii) due to urinary tract infection (uti), five cases of them in pusen group versus one case in lithovue group.All cases managed conservatively by fluids, antibiotics and antipyretics with no serious outcomes.Postoperative hematuria (grade i) were found in four cases, three cases in pusen group and one case in lithovue group.It was managed conservatively with fluids and hemostatic agents.

Manufacturer Narrative

Block b3: exact date unknown, event occurred from june 2020 to jun 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 h6: imdrf patient code e1310 is being used to capture the reportable issue of urinary tract infection.Block h11: block g2: literature source has been corrected.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.

• 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: 18707923
• MDR Text Key: 335402927
• Report Number: 2124215-2024-07992
• 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,Followup
• Report Date: 02/27/2024

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: Not provided
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/27/2024
• 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