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 Pain (1994)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred from september 2019 to september 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 salvado, j.A., elorrieta, e., cabello, j.M., cabello, r., & velasco, a.(2022).Clinical comparison between three single-use flexible ureteroscope models: a real-world experience.Urol int 2022;106:1220-1225.Doi: 10.1159/000527179.Block h6: imdrf patient code e2330 is being used to capture the reportable issue of pain.

Event Description

Boston scientific became aware of an event involving a lithovue flexscope through the article, clinical comparison between three single-use flexible ureteroscope models: a real-world experience, by jose salvado, et al.Per the article, between september 2019 to september 2021, a patient that had a procedure with a lithovue flexscope experienced pain as a postoperative complication, and it was required to place a double-j stent for pain management.

• 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: 18768017
• MDR Text Key: 336117027
• Report Number: 2124215-2024-09329
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 02/23/2024

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