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	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Numbness (2415); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted with an obtryx ii system - halo.As a result of the mesh implant, it was noted that the patient had experienced dyspareunia, chronic and severe pelvic pain, mental and physical pain, permanent injury, permanent and substantial physical deformity, has undergone and likely will undergo further corrective surgery or surgeries, and has suffered financial or economic loss, including, but not limited to obligations for medical services and expenses.On (b)(6) 2022, the patient underwent a pelvic examination, in which it was noted that the sling was palpable at the introitus.In (b)(6) 2023, the patient presented pelvic pain and vaginal bleeding.Examination revealed tenderness along the mesh.Additionally, they noted an area of granulation that had not been identified priorly.On (b)(6) 2023, the patient underwent removal surgery of the sling and a cystoscopy.It was noted that the pain and bleeding was likely related to the device.By (b)(6) 2024, the patient had completed two months of pelvic floor physical therapy; however, symptoms of stress urinary incontinence, bladder pain, groin pain and leg numbness started to worsen.A pelvic magnetic resonance imaging (mri) was ordered.On (b)(6) 2024, the patient presented for worsening left groin pain.After the neurologist's evaluation of the symptoms and the mri results, the physician believed that mesh could be a contributing factor to her left leg numbness and decreased strength.The pelvic mri did not show obvious obturator nerve entrapment.On (b)(6) 2024, an additional mri showed no appreciable sites of nerve entrapment.Specifically, there were no appreciable abnormalities along the course of the right obturator nerve.However, narrowing of the bilateral ischiofemoral and quadratus femoris spaces were noted, along with a mild edema signal in the right quadratus femoris muscle.This appearance would support a clinical diagnosis of ischiofemoral impingement.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of october 14, 2016, was chosen as a best estimate based on the date of mesh implant.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).The explanting physician is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain.E2006 - erosion.E1405- dyspareunia.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.F1202 - disability.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22179446
• Report Number: 2124215-2025-37453
• Device Sequence Number: 8562767
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)190729(10)42170
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 07/29/2019
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0000042170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 07/29/2016
• 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; Disability; Other
• Patient Sex: Female