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 Retention (2119); Urethral Stenosis/Stricture (4501); Urinary Incontinence (4572)
Date of Event	07/13/2023
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 30 hz and total laser energy 60w.The fiber was not stripped or cleaved.There were no other accessory devices introduced into the patient body during the procedure.During the procedure, an incidental urethral stricture was found and urethrotomy was performed concurrently to address the stricture issue, but it was noted that patient had a recurrent stricture of the bulbar urethra.Urinary catheter was placed on the procedure date and removed one day post procedure.The patient discharge medications included colace for constipation prophylaxis, and proscar for bph symptoms prophylaxis.The patient experienced bladder neck stenosis one hundred-thirteen (113) days after the procedure and also incontinence two weeks post procedure.The patient symptoms were reported to be serious and resolved.Thulium laser incision of urethral stricture, bladder neck stenosis with cystolitholapaxy, and the catheterization were performed to resolve the reported patient symptoms.The study facility assessed the recurrent stricture of the bulbar urethra as not related to the holep procedure and not related to the device, and the other patient symptoms as possible related to the holep procedure and not related to the device.
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 30 hz and total laser energy 60w.The fiber was not stripped or cleaved.There were no other accessory devices introduced into the patient body during the procedure.During the procedure, an incidental urethral stricture was found and urethrotomy was performed concurrently to address the stricture issue, but it was noted that patient had a recurrent stricture of the bulbar urethra.Urinary catheter was placed on the procedure date and removed one day post procedure.The patient discharge medications included colace for constipation prophylaxis, and proscar for bph symptoms prophylaxis.The patient experienced bladder neck stenosis one hundred-thirteen (113) days after the procedure and also incontinence two weeks post procedure.The patient symptoms were reported to be non-serious and resolved.Thulium laser incision of urethral stricture, bladder neck stenosis with cystolitholapaxy, and the catheterization were performed to resolve the reported patient symptoms.The study facility assessed the recurrent stricture of the bulbar urethra as not related to the holep procedure and not related to the device, and the incontinence symptoms as possible related to the holep procedure and not related to the device.
Additional Manufacturer Narrative
G1 information corrected 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.

• 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 stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17795589
• Report Number: 2124215-2023-50225
• Device Sequence Number: 17829864
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 09/11/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030125920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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 Sex: Unknown