MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA PULSE ID; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006L8406940
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From operative report: first attempted to perform lithotripsy using the trilogy device at the highest setting but this was making very little impact on the stone due to its very high density.The decision was then made to use a 1000 micron holmium laser fiber for lithotripsy instead.Lithotripsy was then begun using a power of 100 w.However, after about 15 minutes of lithotripsy the fiber broke due to the high power.A new fiber was then placed and using a slightly lower power of 75 w lithotripsy was continued.After lithotripsy was completed on one of the large stones, operative time was approaching 3 hours and the decision was made to stop here for the day.The trilogy was then reinserted and used to clear the remaining dust and fragments.The nephroscope was then removed.A 22 french council tip foley catheter was then inserted through the access sheath into the pouch and the balloon inflated with 10 ml of sterile water.The access sheath was then cut so it could be removed over the catheter.Contrast and saline were then injected through the catheter into the pouch to confirm placement.All wires were then removed.The suprapubic tube was secured using a 2-0 nylon drain stitch.The 14 french foley in the stoma was capped.This concluded the procedure which the patient tolerated well.She was awakened from general anesthesia and transferred to recovery room in stable condition.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 25347558
• Report Number: 25347558
• Device Sequence Number: 16029914
• Product Code: GEX
• UDI-Device Identifier: 08714729978701
• UDI-Public: (01)08714729978701
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026
• Report Date (Section F): 05/22/2026

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 Model Number: M006L8406940
• Device Catalogue Number: M006L8406940
• Device Lot Number: 37426195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 05/22/2026