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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure using an obtryx device for treatment of stress urinary incontinence, the mesh was broken.The event is unclear, and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the mesh detached.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of mesh detachment.
Additional Manufacturer Narrative
Additional information to block b5: describe event or problem received on december 5, 2025.Block h6: device code a0501 captures the reportable event of "anchor" detachment.
Event or Problem Description
It was reported that during a procedure for the treatment of stress urinary incontinence, the device broke while being repositioned inside the patient.The "anchor" detached.The procedure was completed using another of the same device.No patient complications were reported.

• 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: 23758026
• Report Number: 2124215-2025-89831
• Device Sequence Number: 18671366
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)270401(10)33731917
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0033731917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/02/2026
• Date Device Manufactured: 04/01/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Female