MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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

Patient Problem Pain (1994)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred from april 2022 to february 2023.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 chew, b.H., bhojani, n., koo, k.C., bensaadi, k., halawani, a., & wong, v.Kf.(2023).Retrospective first-in-human use of the lithovue elite ureteroscope to measure intrarenal pressure.Wiley online library, 21.Https://bjui-journals.Onlinelibrary.Wiley.Com/doi/10.1111/bju.16173.Block h6: imdrf patient code e2330 is being used to capture the reportable issue of pain.

Event Description

It was reported to boston scientific corporation that a lithovue elite flexscope was used during a ureteroscopy procedure performed on an unknown date.Per the article, a single-arm retrospective observational analysis was performed in 50 consecutive patients undergoing ureteroscopic lithotripsy using the lithovue elite system, with pressure sensing capability between april 2022 to february 2023 at two centres.A pressure bag set at 150mmhg or hand irrigation with a 60cc syringe was used for irrigation and a ureteral access sheath was places at the physician discretion.Median and maximum intrarenal pressure, and relative cumulative time exceeding 20, 40, 60, 80, 100, 120, 140 and 200mmhg per total procedure time were analyzed.Reportedly, one of the patients experienced pain and was re-admitted for pain management.

• Brand Name: LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18759217
• MDR Text Key: 336007240
• Report Number: 2124215-2024-10264
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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?: 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: 02/22/2024
• 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): Hospitalization