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

Model Number	M0067913600
Medical Device Problem Codes	No Display/Image (1183); Device Displays Incorrect Message (2591); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a retrograde intrarenal surgery procedure using a lithovue flexscope, a user message appeared on the screen and the sheath was too big to enter the ureter.The procedure was cancelled as the physician did not want to perform the procedure without an access sheath.No patient complications were reported.This is being reported for an aborted procedure with the patient under sedation.
Event or Problem Description
It was reported that, during a retrograde intrarenal surgery procedure using a lithovue flexscope, a user message appeared on the screen and the sheath was too big to enter the ureter.The procedure was cancelled as the physician do not want to perform the procedure without an access sheath.No patient complications were reported.This is being reported for an aborted procedure with the patient under sedation.
Additional Manufacturer Narrative
Block h11: the lithovue was tested for image on a lithovue touch pc.The device displayed a clear, live image.Analysis identified no articulation in the up direction due to the bowden cable ferrule slipping in the handle, likely due to procedural conditions in conjunction with significant force used on the articulation lever during the procedure, up to the limit of the device design.The articulation failure is likely a secondary issue as it is not related to the reported complaint.With all the available information, boston scientific concludes the reported event was not confirmed.Analysis was not able to confirm the reported complaint as the device displayed a clear, live image.The complaint investigation conclusion code selected is no problem detected, which indicates "the device complaint or problem cannot be confirmed.".
Event or Problem Description
It was reported that, during a retrograde intrarenal surgery procedure using a lithovue flexscope, a user message appeared on the screen and the sheath was too big to enter the ureter.The procedure was cancelled as the physician do not want to perform the procedure without an access sheath.No patient complications were reported.This is being reported for an aborted procedure with the patient under sedation.
Additional Manufacturer Narrative
Block e1: correction to section e: (b)(6).Block h11: the lithovue was tested for image on a lithovue touch pc.The device displayed a clear, live image.Analysis identified no articulation in the up direction due to the bowden cable ferrule slipping in the handle, likely due to procedural conditions in conjunction with significant force used on the articulation lever during the procedure, up to the limit of the device design.The articulation failure is likely a secondary issue as it is not related to the reported complaint.With all the available information, boston scientific concludes the reported event was not confirmed.Analysis was not able to confirm the reported complaint as the device displayed a clear, live image.The complaint investigation conclusion code selected is no problem detected, which indicates "the device complaint or problem cannot be confirmed.".

• Brand Name: LITHOVUE
• Common Device Name: 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: 19795659
• Report Number: 2124215-2024-43646
• Device Sequence Number: 7077379
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2025
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Device Lot Number: 0031875352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 11/18/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/03/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male