MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Dysuria (2684); Movement Disorder (4412); Dyspareunia (4505)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this manufacturer report pertains to the second of two devices implanted in separate procedures.It was reported to boston scientific that an obtryx system - halo was implanted into the patient during a transobturator tape (tot) procedure performed on (b)(6) 2021.Following the procedure, the patient presented for pain several times.The patient noted she never had this kind of pain before the implantation of the prosthesis.A magnetic resonance imaging (mri) was performed.On (b)(6) 2023, a pelvic ultrasound was performed and showed no abnormality of the urethral bladder channel.The entire bladder mucosa was normal, no trigonitis, erosion, stones, abnormal areas, and urothelial lesions.There was a small swelling under the urethral mucosa inside the right ureteral meatus.The cystoscopy was normal apart from the pain on palpation of the vaginal cul-de-sac.The patient is currently having constant pelvic pain, difficulty walking (must lie down as much as possible to be able to walk for two hours), pain in both groins, in the pelvis, in the legs, dyspareunia, labor-like pain, and needle-like pain.She has recurrent urinary infections, problems emptying the bladder, frequent urge to urinate even though the bladder is not full, burning in the urethra, and pain on each side of the vagina.
Additional Manufacturer Narrative
Block h6: imdrf e1405 captures the reportable event of dyspareunia.Imdrf e1301 captures the reportable event of dysuria.Imdrf e2330 captures the reportable event of pain.Imdrf e1310 captures the reportable event of urinary tract infection.

• Brand Name: OBTRYX 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: 18784705
• Report Number: 2124215-2024-11189
• Device Sequence Number: 8332972
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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: 09/25/2021
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0022709333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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; Other
• Patient Sex: Unknown