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); Discomfort (2330)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an obtryx system - halo was implanted into a patient on (b)(6) 2025, and subsequently became exposed through the vagina.Reported complications include vaginal discomfort, erosion, and extrusion.In the physician's opinion, the device contributed to these complications, which are suspected to be due to rejection of the sling by the patient's body.The erosion was identified during a routine follow-up evaluation, with findings localized to the vagina and associated with the sling material.No prior catheter placement, radiation therapy, or other procedures were performed, and no infection was identified.The patient reported discomfort rather than significant pain, describing a sensation of feeling the sling vaginally.To date, the discomfort has not been treated, and further management is under consideration.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion.The following imdrf impact codes capture the reportable events of: f12 - serious injury/ illness/ impairment.

• 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: 24024243
• Report Number: 2124215-2026-01638
• Device Sequence Number: 16097956
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: (01)08714729718987(17)271206(10)35439176
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 01/09/2026

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: M0068505000
• Device Catalogue Number: M0068505000
• Device Lot Number: 0035439176
• 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: 12/10/2025
• Initial Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 12/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female