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

Model Number	M0068504000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572)
Date of Event	04/08/2025
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 april 8, 2025, was chosen as a best estimate based on the date of mesh explant.Block h6: the following imdrf patient codes capture the reportable events of: e2006: mesh erosion.The following imdrf impact codes capture the reportable events of: f1903: vaginal mesh explantation.
Event or Problem Description
It was reported that sometime after implantation, the patient was seen by a urologist due to experienced persistent incontinence.During bulkamid treatment, urethral erosion of the sling was identified.No pain was noted in the thigh roots or obturator foramen.Given the erosion, complete removal of the sling was indicated as the first step in management.On (b)(6) 2025, under general anesthesia, the eroded mesh was successfully removed via vaginal access, and the patient has been feeling much better.
Additional Manufacturer Narrative
Block h11: upon receipt at our quality assurance laboratory, this obtryx system - curved device underwent a thorough analysis.Visual inspection of the device observed that the mesh was partially explanted.The investigation concluded that the most probable cause for this event is known inherent risk of device, which indicates that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2025, was chosen as a best estimate based on the date of mesh explant.Block h6: the following imdrf patient codes capture the reportable events of: e2006 - mesh erosion the following imdrf impact codes capture the reportable events of: f1903 - vaginal mesh explantation.
Event or Problem Description
It was reported that sometime after implantation, the patient was seen by a urologist due to experienced persistent incontinence.During bulkamid treatment, urethral erosion of the sling was identified.No pain was noted in the thigh roots or obturator foramen.Given the erosion, complete removal of the sling was indicated as the first step in management.On (b)(6) 2025, under general anesthesia, the eroded mesh was successfully removed via vaginal access, and the patient has been feeling much better.

• Brand Name: OBTRYX? SYSTEM - CURVED
• 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: 22004004
• Report Number: 2124215-2025-28893
• Device Sequence Number: 9099746
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: (01)08714729718963(17)240621(10)27536132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 06/21/2024
• Device Model Number: M0068504000
• Device Catalogue Number: M0068504000
• Device Lot Number: 0027536132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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; Other
• Patient Age: 49 YR
• Patient Sex: Female