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

Model Number	M0067913600
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block g2: the voluntary user medwatch number is mw5116350.Block h6: imdrf device code a0413 captures the reportable event of material separation.Block h6: impact code f23 is being used to capture the reportable issue of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a cystoscopy, left ureteroscopy with laser lithotripsy and basket stone removal procedure performed on (b)(6) 2023.During the procedure, there was a left ureteral stent exchange, right ureteral stent removal and left retrograde pyelogram.While performing laser lithotripsy on the left ureter/kidney a thin metal like foreign body was found during the flushing process.It was reported the lithovue flexscope had the tip sheared off.In the physicians assessment the metal piece came from either the retrieval basket (unknown manufacturer) or the scope but did occur during the procedure.The instructions for use state the following: do not withdraw a laser fiber back into the ureteroscope while the laser is firing.Doing so may cause patient injury and/or scope damage.Inserting and removing an accessory and application of therapy note: if using a laser lithotripsy system, select a system which features an aiming beam with adjustable intensity or pulse option.Adjust aiming beam intensity or pulsation to allow clear live video image of the lithotripsy target.Do not actuate any accessory device, including laser lithotripsy devices, without a clear endoscopic live video image.If the laser aiming beam cannot be adjusted to provide a satisfactory image, abort the procedure.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16878380
• Report Number: 3005099803-2023-02414
• Device Sequence Number: 7291270
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2025
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Device Lot Number: 0030996982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female