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

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

Patient Problems Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Prolapse (2475); Dyspareunia (4505)

Event Date 08/20/2012

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to august 20, 2012, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.Implant surgeon: (b)(6).Assistant:(b)(6).(b)(6).Surgeon for revision surgery: (b)(6).Assistants: (b)(6).(b)(6).(b)(6).Block h6: imdrf patient codes e1309, e2330, e1310, e2311, e1405 and e1715 capture the reportable events of voiding dysfunction, pain, recurrent utis, discomfort, painful sex, and scar tissue.Imdrf impact code f1905 captures the reportable event of mesh excision surgery.

Event Description

It was reported to boston scientific corporation that an obtryx sling device was implanted into the patient during a laparoscopic-assisted vaginal hysterectomy + bilateral salpingo-oophorectomy + anterior and posterior repair with enterocele + uterosacral vaginal vault suspension + tvt sling + cystoscopy with hydrodistention procedure performed on (b)(6) 2012, for the treatment of pelvic organ prolapse (including uterovaginal prolapse, cystocele, rectocele, enterocele), chronic pelvic pain, and ovarian cyst with hydrosalpinx.Findings also included an enlarged globular uterus at 12 weeks.The patient was taken to the recovery room in stable condition.On (b)(6) 2022, the patient had a revision or removal of the pubovaginal sling, cystoscopy, and urethrocele repair.It was reported that the patient experienced recurrent urinary tract infections on macrobid suppression; pain in joints involving the pelvic region and thigh; and voiding dysfunction.She described the sling as a rubber band and reported that she had to sit and waited sometimes up to 10 minutes before the urine stream came.She also had discomfort in the area of the sling reproduced on the exam with palpation of the sling arms.She also had pain with sexual relations with initial insertion reporting it felt like something was being ripped apart.During the surgery, the sling was identified and appeared to be sitting flat underneath the urethra, with clear fibers.Left and right sling arms were removed.Cystoscopy showed small bilateral urethroceles.There were no complications reported.The patient tolerated the procedure well and was taken to the recovery room in stable condition.

• Brand Name: OBTRYX SYSTEM
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17434790
• MDR Text Key: 320161597
• Report Number: 3005099803-2023-04073
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female