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); Urinary Incontinence (4572)
Date of Event	05/07/2023
Type of Reportable Event	Serious Injury
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 symptom is 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 the holmium laser enucleation of the prostate study procedure for the treatment of benign prostatic hyperplasia (bph).The console setting used for the procedure showed pulse length long, pulse energy 2j, pulse frequency 40hz and total laser energy 80w.The fiber was stripped one time before 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 on the procedure day and removed three days post procedure.The patient discharge medication included sennosides for constipation prophylaxis.The patient began experiencing urinary incontinence fifty-one days post procedure.The patient symptom was reported to be ongoing, not serious, and no action was taken.The study facility assessed the symptom of urinary incontinence as possibly related to the holmium laser enucleation of the prostate procedure and possibly related to the device.
Event or Problem Description
The patient underwent the holmium laser enucleation of the prostate study procedure for the treatment of benign prostatic hyperplasia (bph).The console setting used for the procedure showed pulse length long, pulse energy 2j, pulse frequency 40hz and total laser energy 80w.The fiber was stripped one time before 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 on the procedure day and removed three days post procedure.The patient discharge medication included sennosides for constipation prophylaxis.The patient began experiencing irritative urinary symptoms on the procedure day (post procedure).The patient symptoms were reported to be not serious, ongoing and no action was taken.The study facility assessed irritative urinary symptoms as probably related to holmium laser enucleation of the prostate procedure and possibly related to the device.Also, the patient began experiencing urinary incontinence fifty-one days post procedure.The patient symptom was reported to be not serious, and no action was taken.The patient symptom of urinary incontinence was reported to be resolved forty-seven days post onset symptom.The study facility assessed the symptom of urinary incontinence as possibly related to the holmium laser enucleation of the prostate procedure and possibly related to the device.
Additional Manufacturer Narrative
B5.Describe event or problem updated.H6.Patient codes updated.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.
Additional Manufacturer Narrative
B5.Describe event or problem updated.H6.Patient codes updated.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 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 the holmium laser enucleation of the prostate study procedure for the treatment of benign prostatic hyperplasia (bph).The console setting used for the procedure showed pulse length long, pulse energy 2j, pulse frequency 40hz and total laser energy 80w.The fiber was stripped one time before 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 on the procedure day and removed three days post procedure.The patient discharge medication included sennosides for constipation prophylaxis.The patient began experiencing irritative urinary symptoms on the procedure day (post procedure).The patient symptoms were reported to be not serious, ongoing and no action was taken.The study facility assessed irritative urinary symptoms as probably related to holmium laser enucleation of the prostate procedure and possibly related to the device.Also, the patient began experiencing urinary incontinence fifty-one days post procedure.The patient symptom was reported to be not serious, and no action was taken.The patient symptom of urinary incontinence was reported to be resolved forty-seven days post onset symptom.The study facility assessed the symptom of urinary incontinence as possibly related to the holmium laser enucleation of the prostate 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: 17125268
• Report Number: 2124215-2023-30576
• Device Sequence Number: 7388242
• Product Code: GEX
• UDI-Device Identifier: 08714729978695
• UDI-Public: 08714729978695
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,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: 08/22/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030003630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 09/15/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/27/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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: 65 YR
• Patient Sex: Male