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	Urinary Frequency / Polyuria (2275); Dysuria (2684)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
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 30hz and total laser energy 60w.The fiber was not stripped during the 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.A urinary catheter was placed after the procedure and removed the next day.The patient discharge medication included senna and colace for constipation prophylaxis, keflex for post-operative antibiotic prophylaxis, and proscar for prevention of bph symptoms.The patient began experiencing dysuria and urinary frequency sixty-six (66) days post procedure.The patient symptoms were reported to be resolved ((b)(6) 2023), and not serious.The study facility assessed the dysuria and the urinary frequency as possibly related to the holmium laser enucleation of the prostate 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 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.
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 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.Correction to field b5: describe event or problem.
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 30hz and total laser energy 60w.The fiber was not stripped during the 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.A urinary catheter was placed after the procedure and removed the next day.The patient discharge medication included senna and colace for constipation prophylaxis, keflex for post-operative antibiotic prophylaxis, and proscar for prevention of bph symptoms.The patient began experiencing dysuria and urinary frequency sixty-six (66) days post procedure.The patient symptoms were reported to be resolved, and not serious.The dysuria was resolved on 28jun2023 and the urinary frequency was resolved on 08jun2023.The study facility assessed the dysuria and the urinary frequency as possibly related to the holmium laser enucleation of the prostate 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 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.Correction to field b5: describe event or problem.Correction to g1: manufacturing site information.
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 30hz and total laser energy 60w.The fiber was not stripped during the 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.A urinary catheter was placed after the procedure and removed the next day.The patient discharge medication included senna and colace for constipation prophylaxis, keflex for post-operative antibiotic prophylaxis, and proscar for prevention of bph symptoms.The patient began experiencing dysuria and urinary frequency sixty-six (66) days post procedure.The patient symptoms were reported to be resolved, and not serious.The dysuria was resolved on (b)(6) 2023 and the urinary frequency was resolved on (b)(6) 2023.The study facility assessed the dysuria and the urinary frequency as possibly related to the holmium laser enucleation of the prostate 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; 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: 17337474
• Report Number: 2124215-2023-37125
• Device Sequence Number: 20452391
• Product Code: GEX
• UDI-Device Identifier: 08714729978749
• UDI-Public: 08714729978749
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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: 08/05/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0029903652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/15/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/15/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2022
• 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: 70 YR
• Patient Sex: Male