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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Dysuria (2684); Movement Disorder (4412); Dyspareunia (4505)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.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.

Event Description

Note: this manufacturer report pertains to the first 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) 2019.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.

• Type of Device: 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: 18784734
• MDR Text Key: 336290774
• Report Number: 2124215-2024-11239
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other