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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mid-urethral sling procedure, using an obtryx system - halo device, the mesh was torn.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Block e1: complete address of the healthcare facility: (b)(6).Block h6: device code a0414 captures the reportable event of mesh torn.
Additional Manufacturer Narrative
Boston scientific concludes that the reported allegation of the mesh torn could not be confirmed.The device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on the information available, a conclusion code of cause not established was assigned to this investigation since the investigation was unable to determine a probable cause for the complaint event based on the available information.(b)(6).Device code a0414 captures the reportable event of mesh torn.
Event or Problem Description
It was reported that during a mid-urethral sling procedure using an obtryx system - halo device, the mesh was torn.The procedure was completed with another of the same device.No patient complications reported.
Event or Problem Description
It was reported that during a mid-urethral sling procedure using an obtryx system - halo device, the mesh was torn.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Block h11: with all the available information, boston scientific concludes that the reported allegation of the mesh torn could not be confirmed.The device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review performed for the obtryx lynx device confirmed that the event of mesh torn material is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the obtryx lynx device is acceptable.Based on the information available, a conclusion code of cause not established was assigned to this investigation since the investigation was unable to determine a probable cause for the complaint event based on the available information.Block e1: complete address of the healthcare facility: (b)(6).Block h6: device code a0414 captures the reportable event of mesh torn.

• 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: 24484576
• Report Number: 2124215-2026-11396
• Device Sequence Number: 5104982
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: (01)08714729718987(17)270211(10)33402947
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K040787
• 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,Followup
• Report Date (Section B): 04/29/2026

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: 0033402947
• 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: 02/07/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/22/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/13/2026; 04/29/2026
• Date Device Manufactured: 02/12/2024
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 67 KG