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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable code of mesh torn.
Event or Problem Description
It was reported that during a transobturator tape procedure using an obtryx ii system - halo device, the mesh was broken.The event is unclear, and boston scientific has been unable to obtain additional information surrounding this event outcome to date, despite good faith efforts.The event description may suggest that the mesh was torn.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable code of mesh torn.Block h11: correction to block d4: unique identifier (udi) number.
Event or Problem Description
It was reported that during a transobturator tape procedure using an obtryx ii system - halo device, the mesh was broken.The event is unclear, and boston scientific has been unable to obtain additional information surrounding this event outcome to date, despite good faith efforts.The event description may suggest that the mesh was torn.

• 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: 21763739
• Report Number: 2124215-2025-19397
• Device Sequence Number: 21017315
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/22/2026

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: 0032782886
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 08/28/2026
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/04/2025; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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 Sex: Female