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	Abdominal Pain (1685); Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	09/13/2016
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 september 13, 2016, was chosen as a best estimate based on the date of the mesh was implanted.Blocks d4, h4: the complainant was unable to report the batch/lot number of the device; therefore, the manufacture date and expiration date are unknown.Block d4 unique identifier (udi) #: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).The revising physician is: (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2006 - captures the reported event of erosion and extrusion of mesh.E1401 - captures the reported event of vaginal discharge.E1301 - captures the reported event of dysuria.E1405 - captures the reported event of dyspareunia.E1906 - captures the reported event of atrophic vaginitis.E2330 - captures the reported event of chronic migraines, pelvic pain, back pain, and limb pain.E2308 - captures the reported event of disfigurement.E2401 - captures the reported event of severe and debilitating injuries.E0206 - captures the reported event of mental pain.The imdrf impact code capture the reportable event of: f1905 - captures the reportable event of patient underwent a partial mesh revision.
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 mesh erosion and exposure, vaginal spotting, vaginal discharge, dysuria, dyspareunia, chronic abdominal pain requiring treatment with trigger point injections, atrophic vaginitis, chronic migraines, pelvic pain, back pain, and limb pain.Subsequently, the patient underwent a mesh revision surgery on (b)(6) 2023.The patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm as a result of the implanted device.Additionally, the patient claims that she may have to undergo additional surgery, and may in the future suffer, damages such as, significant pain, severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, medical expenses due 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: 23761850
• Report Number: 2124215-2025-90000
• Device Sequence Number: 10131706
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/09/2025

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 Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/09/2025
• 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