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

Model Number M0068505110

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

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422); Prolapse (2475); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Insufficient Information (4580)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date of the excision of vaginal mesh surgery.This event was reported by the patient's legal representation.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that the patient was diagnosed with genuine stress urinary incontinence by urodynamics and symptomatic cystocele.On (b)(6) 2017, she was implanted with an obtryx ii system - halo device during a laparoscopic bilateral salphingetcomy, anterior colporrhaphy and vaginal hammock using bsc transobturator tape procedure.The patient was transferred to recovery room in stable condition after the procedure.On (b)(6) 2021, the patient underwent sling lysis and excision of vaginal mesh urethrolysis, cystourethroscopy, total laparoscopic hysterectomy, laparoscopic vaginal vault suspension, posterior colporrhaphy and perineorrhaphy procedures due to cystocele, uterovaginal prolapse, rectocele, defecatory dysfunction, incomplete bladder emptying, voiding dysfunction, bladder outlet obstruction and dyspareunia.During the procedures, the following have also been noted: thick adhesions in lower uterine segment at the level of the bladder peritoneum; powder burn endometriotic lesion in right pelvic side wall; previous transobturator sling in situ proximal to the bladder neck.Following sling lysis, 0.5 cm of redundant blue mesh sling were excised; slightly enlarged otherwise normal ovaries; and large defect along mid to distal rectovaginal fascia which was repaired in site-specific fashion and the remainder of rectocele repaired in traditional fashion.Furthermore, cystoscopy revealed grossly unremarkable 360 degree survey of the bladder without evidence of suture, injury, mesh, or foreign body in the bladder.Brisk urine efflux seen from bilateral ureteral orifices.Results of pathology test for sling mesh, uterus and cervix specimen showed segment of fibrovascular tissue with synthetic mesh material with associated histiocytic reaction and granulation tissue, no pathologic change to the cervix, endometrium in secretory phase, and focal submucosal scarring in myometrium consistent with prior endometrial ablation procedure.

• Brand Name: OBTRYX II SYSTEM - HALO
• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12373083
• MDR Text Key: 268321934
• Report Number: 3005099803-2021-04236
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

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
• Device Expiration Date: 11/29/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0000049917
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR