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

Model Number	2130-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematuria (2558); Dysuria (2684)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent lithotripsy study procedure on right ureter for stone treatment.The console setting used for the procedure showed pulse length long, pulse energy 0.6j, pulse frequency 6hz and total laser energy 3.6w.The fiber was not stripped or cleaved.The fiber was used with storz flexible scope and moses pulse console.There were no other accessory devices introduced into the patient body during the procedure.No adverse events were noted during the procedure and the procedure was completed without complications.6 x 26 french ureteral stent was placed on the procedure day and removed on twenty days post procedure.The patient discharge medications included tylenol for pain prophylaxis, bactrim ds for postoperative antibiotic prophylaxis, flomax for stone removal, and zyloprim for history of uric acid stones and elevated uric acid in blood.The patient began experiencing dysuria and hematuria fifty-one days post procedure.The patient symptoms were reported to be not serious.Medication (ciprofloxacin) was provided to the patient.The patient symptoms were reported to be resolved (date unknown).The study facility assessed the patient symptoms as possibly related to the lithotripsy procedure and not related to the device.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with this type of treatment and is noted as such in the device direction for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
The patient underwent lithotripsy study procedure on right ureter for stone treatment.The console setting used for the procedure showed pulse length long, pulse energy 0.6j, pulse frequency 6hz and total laser energy 3.6w.The fiber was not stripped or cleaved.The fiber was used with storz flexible scope and moses pulse console.There were no other accessory devices introduced into the patient body during the procedure.No adverse events were noted during the procedure and the procedure was completed without complications.6 x 26 french ureteral stent was placed on the procedure day and removed on twenty days post procedure.The patient discharge medications included tylenol for pain prophylaxis, bactrim ds for postoperative antibiotic prophylaxis, flomax for stone removal, and zyloprim for history of uric acid stones and elevated uric acid in blood.The patient began experiencing dysuria and hematuria fifty-one days post procedure.The patient symptoms were reported to be not serious.Medication (ciprofloxacin) was provided to the patient.The patient symptoms were reported to be resolved (date unknown).The study facility assessed the patient symptoms as possibly related to the lithotripsy procedure and not related to the device.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17101345
• Report Number: 2124215-2023-29759
• Device Sequence Number: 19315853
• Product Code: GEX
• UDI-Device Identifier: 08714729978763
• UDI-Public: 08714729978763
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030092860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male