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 Erosion (1750); Pain (1994); Scar Tissue (2060); Unspecified Kidney or Urinary Problem (4503)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2017, the 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.The implant surgeon is: dr.(b)(6).Explant surgery: dr.(b)(6).Block h6: imdrf patient codes e2006, e2330, e1715 and e1311 capture the reportable events of sling was deeply embedded into the spongiosum, pelvic pain, scarring, and high-tone pelvic floor dysfunction.Imdrf impact codes f1903 and f2301 capture the reportable events of complete sling removal and placement of an immediate autologous rectus fascia pubovaginal sling.

Event Description

It was reported to boston scientific corporation that a boston scientific transobturator mid-urethral sling device was implanted into the patient using halo introducers during a total abdominal hysterectomy + placement of tension free mid-urethral sling procedure performed on (b)(6) 2017, for the treatment of dyspareunia, dysmenorrhea, menorrhagia, pelvic pain, urinary stress incontinence.The patient went to recovery room in stable condition.On (b)(6) 2022, had to undergo catheter placement, removal of tot and mini sling, rectus fascia harvest, and pubovaginal sling cystourethropexy with autologous rectus fascia procedures.The patient presented with a history of pelvic pain and persistent urinary symptoms following sling placement.She had decided to proceed with removal of the sling and placement of an immediate autologous rectus fascia pubovaginal sling.The patient had evidence of separation of the spongiosum in the midline scar and thickened tissue to either side of the urethra consistent with the previous surgery, as well as the potential incision into the tissues of the spongiosum.After mobilizing the vaginal tissues, the left arm of the transobturator sling was identified.This appeared to traverse very close to the vaginal epithelium but did not perforate.There was a fair amount of scarring with the left arm.The sling was also deeply embedded into the spongiosum, and great care was taken to dissect if free from the investing tissues.The entire transobturator sling was then removed.The mini sling was in a much more distal location.The anchor of the mini sling remained somewhat embedded in the obturator fascia and was removed as much of it as possible from the right side and the entire anchor from the left side.At the end of the procedure, the patient tolerated it well and was taken back 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: 17783150
• MDR Text Key: 323860688
• Report Number: 3005099803-2023-05063
• 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: 09/20/2023

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
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/20/2023
• 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: 43 YR
• Patient Sex: Female