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	Micturition Urgency (1871); Urinary Frequency / Polyuria (2275); Dysuria (2684)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: estimated.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 implant of these devices as indicated in the instructions 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 a holmium laser enucleation of the prostate (holep) study procedure for the treatment of benign prostatic hyperplasia (bph).The console setting used for the procedure showed pulse length long, pulse energy 2 joules, pulse frequency 40 hz and total laser energy 80w.The fiber was stripped once before procedure.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.Urinary catheter was placed on the procedure day and removed one day post procedure at discharge.The patient discharge medications included miralax for constipation prophylaxis and pyridium for painful urination prophylaxis.The patient experienced irritative urinary symptoms the same day the procedure was performed (post procedure).The patient symptoms were reported to be not serious.Medication was administered and the dose was increased.The patient symptoms were reported to be on going.The study facility assessed the patient symptoms as possibly related to the lithotripsy procedure and possibly related to the device.
Additional Manufacturer Narrative
B3.Date of event: estimated.Correction: g1 manufacturing site information 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 implant of these devices as indicated in the instructions 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 a holmium laser enucleation of the prostate (holep) study procedure for the treatment of benign prostatic hyperplasia (bph).The console setting used for the procedure showed pulse length long, pulse energy 2 joules, pulse frequency 40 hz and total laser energy 80w.The fiber was stripped once before procedure.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.Urinary catheter was placed on the procedure day and removed one day post procedure at discharge.The patient discharge medications included miralax for constipation prophylaxis and pyridium for painful urination prophylaxis.The patient experienced irritative urinary symptoms the same day the procedure was performed (post procedure).The patient symptoms were reported to be not serious.Medication was administered and the dose was increased.The patient symptoms were reported to be on going.The study facility assessed the patient symptoms as possibly related to the lithotripsy procedure and possibly 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan MA 14110 ; MY 14110
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17410486
• Report Number: 2124215-2023-39491
• Device Sequence Number: 12508260
• Product Code: GEX
• UDI-Device Identifier: 08714729978695
• UDI-Public: 08714729978695
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 09/18/2023

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: 09/12/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030134077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male