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

Model Number	M0068504110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Deformity/ Disfigurement (2360); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks d4, h4: the suspect device lot number is unknown; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - vaginal pain.E1906 - recurrent infection.The following imdrf impact code capture the reportable event of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient underwent a transobturator urethral sling procedure where an obtryx ii system - curved was implanted.During the same procedure, cystoscopy was also performed.On (b)(6) 2024, the patient was diagnosed with recurrent infections and vaginal pain after sling replacement.Operative findings revealed deep seated sling curled to the left side.The urethra was distorted and elevated from the sling underneath the proximal to mid urethral region.The bladder was trabeculated, in grade four, and had several areas of chronic cystitis cystica.A small narrow deaver was placed, which allowed a better examination of the vaginal wall.The patient had posterior repair with fairly high posterior ridge and anteriorly had a prior colporrhaphy scar.The sling was seen elevating the proximal urethra and was quite tented up.A short transverse incision was made at the level of the mid urethra, along the anterior vaginal wall, and through that incision, the sling was discovered deep on the left side as noted on preoperative ultrasound and curled.It was divided at the four o'clock position and carefully tracked underneath the urethra from left to right.After the suburethral release, cystoscopy was repeated.Normal urethra, with no distortion and a round configuration was revealed.No urethral injury was noted.
Additional Manufacturer Narrative
Block h11: blocks b2, b5, d4, and h4 have been updated based on the additional information received on july 15, 2025.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - vaginal pain.E1906 - recurrent infection.The following imdrf impact code capture the reportable event of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient underwent a transobturator urethral sling procedure where an obtryx ii system - curved was implanted.During the same procedure, cystoscopy was also performed.On (b)(6) 2024, the patient was diagnosed with recurrent infections and vaginal pain after sling replacement.Operative findings revealed deep seated sling curled to the left side.The urethra was distorted and elevated from the sling underneath the proximal to mid urethral region.The bladder was trabeculated, in grade four, and had several areas of chronic cystitis cystica.A small narrow deaver was placed, which allowed a better examination of the vaginal wall.The patient had posterior repair with fairly high posterior ridge and anteriorly had a prior colporrhaphy scar.The sling was seen elevating the proximal urethra and was quite tented up.A short transverse incision was made at the level of the mid urethra, along the anterior vaginal wall, and through that incision, the sling was discovered deep on the left side as noted on preoperative ultrasound and curled.It was divided at the four o'clock position and carefully tracked underneath the urethra from left to right.After the suburethral release, cystoscopy was repeated.Normal urethra, with no distortion and a round configuration was revealed.No urethral injury was noted.Additional information received: sometime after mesh implantation, the patient experienced dyspareunia, mesh erosion, persistent vaginal and urethral pain, urinary dysfunction (dysuria, urgency, incomplete emptying, voiding impairment), recurrent infections, urethral disfigurement, scarring, chronic cystitis, and loss of enjoyment of life.Additionally, she claimed to have suffered severe pain, physical pain, mental anguish, and physical impairment as a result of the incident, both in the past and, with reasonable probability, will continue to experience such harm in the future.She also claims to have incurred medical expenses to date and anticipates additional costs moving forward.

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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: 19761924
• Report Number: 2124215-2024-43726
• Device Sequence Number: 8513569
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: (01)08714729839255(17)211104(10)22889128
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 11/04/2021
• Device Model Number: M0068504110
• Device Catalogue Number: M0068504110
• Device Lot Number: 0022889128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 11/05/2018
• 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: Female