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	Abscess (1690); Purulent Discharge (1812); Incontinence (1928); Unspecified Infection (1930); Necrosis (1971); Prolapse (2475); Unspecified Kidney or Urinary Problem (4503)
Date of Event	01/23/2020
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 january 23, 2020, 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 revising physician is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1906 - infection e2327 - necrotic areas along the sling e231501 - purulent discharge.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient underwent an implant procedure on (b)(6) 2020, in which an obtryx ii system - halo was placed following a long history of mixed incontinence that had worsened over the years.The patient noted that prior to the placement, she would experience nocturia and leakage worsened with physical activity, coughing and sneezing.On (b)(6) 2024, the patient was diagnosed with hypermobility of the urethra, mixed incontinence, and cystocele; therefore, a revision surgery was performed.During the procedure, a pinhole defect was identified in the anterior vaginal wall at approximately the mid-vaginal level.An incision was made, revealing purulence and discharge surrounding the previously placed sling.The mesh was not encapsulated and was easily visible.The sling was removed with gentle traction, and the transobturator arms were excised using tenotomy scissors.Following removal, necrotic debris was observed along the sling bed, and thorough debridement of necrotic tissue was performed.The placement of a new sling was abandoned due to the presence of active infection.The vaginal mucosal edges were refreshed by excising the incision margins, after which the vaginal mucosa was reapproximated using a loose running 2-0 vicryl suture.The foley catheter was temporarily removed, and cystoscopy was performed, demonstrating no evidence of bladder injury or mucosal lesions.The bilateral ureteral orifices were in normal anatomic position with clear efflux observed.Cystoscopy was then discontinued, the foley catheter was replaced, and the patient was returned from the dorsolithotomy position and awakened from general anesthesia.There were no further patient complications.
Additional Manufacturer Narrative
Block h11: correction to block e1: initial reporter title, initial reporter first name, initial reporter last name, initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter state, initial reporter zip/post code, initial reporter phone, initial reporter fax.With all the available information, boston scientific concludes that the reported adverse events of prolapse, incontinence, infection, unspecified kidney or urinary problem, necrosis, purulent discharge, and abscess are known risks of the surgical procedure.The device was not returned for evaluation; therefore, a technical analysis could not be performed, and the reported incident could not be confirmed.The device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.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.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 january 23, 2020, 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: dr.(b)(6).The revising physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1906 - infection.E2327 - necrotic areas along the sling.E231501 - purulent discharge.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.
Event or Problem Description
It was reported that the patient underwent an implant procedure on (b)(6) 2020, in which an obtryx ii system - halo was placed following a long history of mixed incontinence that had worsened over the years.The patient noted that prior to the placement, she would experience nocturia and leakage worsened with physical activity, coughing and sneezing.On (b)(6) 2024, the patient was diagnosed with hypermobility of the urethra, mixed incontinence, and cystocele; therefore, a revision surgery was performed.During the procedure, a pinhole defect was identified in the anterior vaginal wall at approximately the mid-vaginal level.An incision was made, revealing purulence and discharge surrounding the previously placed sling.The mesh was not encapsulated and was easily visible.The sling was removed with gentle traction, and the transobturator arms were excised using tenotomy scissors.Following removal, necrotic debris was observed along the sling bed, and thorough debridement of necrotic tissue was performed.The placement of a new sling was abandoned due to the presence of active infection.The vaginal mucosal edges were refreshed by excising the incision margins, after which the vaginal mucosa was reapproximated using a loose running 2-0 vicryl suture.The foley catheter was temporarily removed, and cystoscopy was performed, demonstrating no evidence of bladder injury or mucosal lesions.The bilateral ureteral orifices were in normal anatomic position with clear efflux observed.Cystoscopy was then discontinued, the foley catheter was replaced, and the patient was returned from the dorsolithotomy position and awakened from general anesthesia.There were no further patient complications.

• 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: 24335168
• Report Number: 2124215-2026-08300
• Device Sequence Number: 20088181
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)220204(10)23299265
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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 Expiration Date: 02/04/2022
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0023299265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 02/05/2019
• 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: Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female