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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had been pain-free following a trans obturator tape (tot) procedure in 2020 using an obtryx ii system - halo device.However, in late (b)(6) 2025, the patient began experiencing a urinary tract infection (uti) accompanied by various types of pain, including vaginal pain, leg pain, and pain in the left buttock, as well as a burning sensation in the bladder.Despite multiple medical consultations and treatment with painkillers and anti-inflammatory medications, the patient's symptoms progressively worsened and eventually became unbearable.Clinical observation revealed that the left side of the sling was located in close proximity to the vaginal wall, and the patient experienced pain in the region of the left obturator foramen.Due to the persistent and severe nature of the symptoms, the patient underwent surgical removal of the left portion of the sling on (b)(6) 2025.
Additional Manufacturer Narrative
Block h6: the imdrf patient codes capture the reportable events of: patient code e1310 captures the reportable event of urinary tract infection.Patient code e2330 captures the reportable event of various types of pain, including vaginal pain, leg pain, and pain in the left buttock.Patient code e1705 captures the reportable event of burning sensation in the bladder.The imdrf impact code capture the reportable event of: impact code f2303 captures the reportable event of painkillers and anti-inflammatory medication.Impact code f2303 captures the reportable event of surgical removal of the left portion of the sling.

• 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: 22621080
• Report Number: 2124215-2025-48662
• Device Sequence Number: 18387484
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)220914(10)24433441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 09/14/2022
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0024433441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 09/15/2019
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 53 KG