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	Abscess (1690); Purulent Discharge (1812); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)
Date of Event	01/23/2020
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 (b)(6) 2020, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).The revising physician: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1906 - captures the reportable event of infection.E2330 - captures the reportable event of severe pelvic cramping and pain.E0506 - captures the reportable event of bleeding.E2327 - captures the reportable event of necrotic tissue.E231501 - captures the reportable event of purulent discharge.E172001 - captures the reportable event of abscess.E2308 - captures the reportable event of disfigurement.E0206 - captures the reportable event of embarrassment and mental pain.E2401 - captures the reportable event of severe and debilitating injuries.The following imdrf impact code captures the reportable event of: f1905 - captures the reportable event of revision surgery.F1901 - captures the reportable event of removal and debridement of necrotic tissue.
Event or Problem Description
It was reported that the patient had an obtryx ii system - halo implanted during a procedure and has since experienced complications, including infection, severe pelvic cramping and pain, bleeding, purulence, necrotic tissue, abscess, recurrence, removal and debridement of necrotic tissue, and subsequent removal surgery.The patient later underwent a revision surgery on or about (b)(6) 2024.As a result of the implanted device, the patient suffered significant pain, unnecessary expenses, embarrassment, disfigurement, and harm.Additionally, the patient claims that she may have to undergo further surgery and may, in the future, suffer damages such as severe and debilitating injuries, serious bodily harm, mental and physical pain and suffering, and additional medical expenses related to the implantation of the device.

• 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: 23871402
• Report Number: 2124215-2025-92421
• Device Sequence Number: 4438205
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)220204(10)23299265
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 02/04/2022
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0023299265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 02/05/2019
• 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
• Patient Sex: Female