MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068505110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency / Polyuria (2275); Depression (2361); Dyspareunia (4505); Localized Skin Lesion (4542); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of may 10, 2022, was chosen as a best estimate based on the date of mesh implant.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain, e1310 - urinary tract infection, e1405 - dyspareunia.The following imdrf impact codes capture the reportable events of: f1202 - disability.
Event or Problem Description
It was reported that an obtryx ii system - curved was implanted into the patient for the treatment of stress urinary incontinence.Sometime after implantation, the patient was seen by a urologist due to total incontinence with full and painful bladder after a maximum of two hours.She can no longer run, bend down, or jump without experiencing urinary leakage.Whenever she stretches, turns, get up during night-time, it leaks.She had several awakenings during night because of bladder pain, as if it was completely full.Constant burning sensation and itching were also present, along with urinary tract infections, small pimples on the clitoris and to the vaginal entrance, and vaginal odor.She also noted pain in her right thigh which has been evaluated and determined not to be related to a venous condition.During sexual intercourse, the patient experiences severe urinary loss and pain.The urologist first proposed botox injections, then changed the recommendation to a tension free vaginal tape (tvt) implant.The patient refused the tvt due to the complications already experienced with the transobturator tape (tot) and the desire to avoid further risks.Since then, the patient has not received adequate follow-up care.Currently, the patient has had a very disabling problem in everyday- painful bladder and the bladder that leaks at the slightest opportunity.Due to her urinary leakage, she had to refuse to play with her 10-year-old child since 2022.Furthermore, her physician told her about depression following her worries regarding the mesh implant.The patient has become socially withdrawn, had trouble going out, and has had fear for traveling of not knowing how to compose herself with her urinary leakage.She often cried even in front of her doctor, just talking about the consequences of this procedure.This also has an impact on her life as a couple, as she no longer has a libido due to her urinating during intercourse.

• Brand Name: OBTRYX II SYSTEM - HALO
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22060498
• Report Number: 2124215-2025-30452
• Device Sequence Number: 15540662
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)250210(10)28852536
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 02/10/2025
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0028852536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 02/11/2022
• 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; Disability
• Patient Sex: Female