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

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the obtryx system - halo implanted during a procedure and has since experienced complications.These include mesh erosion and exposure, vaginal bleeding, discomfort, difficulty urinating, and dyspareunia.Subsequently, the patient underwent mesh revision surgery on (b)(6) 2024.She also claimed to have suffered severe pain, unnecessary expenses, embarrassment, disfigurement, and harm as a result of the implantation.Additionally, the patient claims that she may need to undergo further surgery and may, in the future, suffer damages such as significant pain, severe and debilitating injuries, serious bodily harm, mental and physical pain and suffering, and medical expenses due to the implantation of the device.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of august 16, 2019, 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 physician is: dr.(b)(6).(b)(6) hospital women's center.(b)(6).The revising physician is: dr.(b)(6).(b)(6) health specialists.(b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2006 - captures the reportable event of mesh erosion and exposure.E0506 - captures the reportable event of vaginal bleeding.E2311 - captures the reportable event of adhesions.E2401 - captures the reportable event of difficulty urinating, severe and debilitating pain.E1405 - captures the reportable event of dyspareunia.E2330 - captures the reportable event of pain.E2308 - captures the reportable event of disfigurement.E0206 - captures the reportable event of mental pain and loss of enjoyment of life.The imdrf impact code capture the reportable event of: f1905 - captures the reportable event of mesh revision surgery.

• Brand Name: OBTRYX 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: 22852264
• Report Number: 2124215-2025-54242
• Device Sequence Number: 15547020
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: (01)08714729718987(17)210814(10)22517186
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• 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
• Report Date (Section B): 08/20/2025

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: 08/14/2021
• Device Model Number: M0068505000
• Device Catalogue Number: M0068505000
• Device Lot Number: 0022517186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 08/15/2018
• 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
• Patient Sex: Female