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	Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Sometime after implantation, the patient had recurring urinary tract infections (uti), pyelonephritis, a malfunctioning bladder, and urinary retention of 400 ml to 600 ml.She also reported persistent vulvar pain, left-sided stiffness, pain between the thighs, and shooting pains in the left side and upper thighs.She was hospitalized and received antibiotic treatments, including injections more than three times annually, in addition to oral antibiotics.Since october 2023, the frequency of uti and pain has increased.Under her physician's supervision, she has been performing self-catheterization three times daily since on (b)(6) 2025.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of february 20, 2018, was chosen as a best estimate based on the date of mesh implant.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain, e1310 - recurring urinary tract infection, e1906 - pyelonephritis, e1309 - urinary retention.The following imdrf impact codes capture the reportable events of: f08 - hospitalization, f2301 - self-catheterization.

• 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: 22060923
• Report Number: 2124215-2025-30459
• Device Sequence Number: 7812520
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)200501(10)64330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 05/01/2020
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0000064330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 05/02/2017
• 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; Hospitalization; Other
• Patient Sex: Female