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

Model Number	M0068505110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); Dyspareunia (4505); Unspecified Tissue Injury (4559)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of november 6, 2018, was chosen as a best estimate based on the date of mesh implant.Block e1: this event was reported by the patient's legal representation.The implanting physicians are: dr.O(b)(6) (primary) and dr.(b)(6) (co-surgeon) (b)(6) hospital (b)(6) the explanting physician is dr.(b)(6) (b)(6) hospital (b)(6) block h6: the following imdrf patient codes capture the reportable events of: e2006 - erosion.E2330 - pain.E1405 - dyspareunia.E1906 - infection.E1310 - urinary tract infection.The following imdrf impact codes capture the reportable events of: f1903 - mesh removal block h11: the device was not returned for evaluation; therefore, a technical analysis could not be performed.With all available information, bsc concludes that the reported adverse events are known risks of the surgical procedure.Therefore, the investigation concluded that the most probable root cause for this complaint is known inherent risk of device which indicates that the reported adverse event is known and documented in the labeling.
Event or Problem Description
It was reported that the patient underwent a total vaginal hysterectomy procedure where an obtryx ii system - halo was implanted on (b)(6) 2018, for the treatment of pelvic organ prolapse and stress urinary incontinence.During the same procedure, bilateral salpingectomy, right oophorectomy, mccall culdoplasty, posterior vaginal repair, transobturator midurethral sling and cystoscopy were also performed.Following the implantation, on (b)(6) 2025, the patient was diagnosed with complication of the vaginal mesh, rectocele, pelvic relaxation due to midline cystocele, disease of urinary tract, exposed transvaginal mesh, and dyspareunia.She underwent cystoscopy, excision of vaginal mesh, transvaginal removal of tot (transobturator) mesh sling, anterior and posterior colporrhapy repair with perineal repair, vaginal reconstruction after sling removal and rectocele repair.The patient had experienced pain in the vaginal area, dyspareunia, and exposed and presumed infected foreign body in the vaginal cavity.During the procedure, the mesh was found to be exposed, suggesting that the vaginal tissue may have been buttonholed during the original tot placement.A section lateral to the midline incision showed a full-thickness fold of visible mesh.A foley catheter was placed, and a vasoactive solution with vasopressin was injected into the anterior vaginal wall for hydrodissection.Given the difficulty of office examination and cystoscopy had been limited due to the patient's modesty and overall, pain, an intraoperative cystoscopy was performed after removal of the foley catheter to further evaluate the urethra and bladder.The bladder was emptied, the foley catheter removed, cystoscopy performed, and the foley was replaced afterwards.Cystoscopy was then performed, the bladder was systematically examined revealing no mesh within the bladder, bladder neck, or urethra; however, the urethra was notably friable, with a gland that had an open neck at the 7 o'clock position in the distal urethra.The cystoscope was removed, the foley catheter replaced, and the bladder drained.A midline incision measuring approximately 1.5 cm was made about 1 cm from the meatus and clearly still in the mid urethral.Dissection was carried laterally on the right all the way to the rami, where a capsule over what looked like the suspected mesh location was noted.A transverse incision was made to release the mesh from the vaginal epithelium, followed by a transverse incision from the midline to the exposed mesh on the left.The vaginal wall was microdissected off the exposed mesh, creating a partial cruciate incision in the vaginal epithelium that required later reconstruction.The vaginal tissue was freed up and the dissection carried up to the rami on the left side, with mesh was seen through its capsule.Fine metzenbaum were used to release the capsule and reveal the mesh, which was most easily to do this on the patient's midline or toward the right side.Once mesh was mobilized anteriorly, dissection the underside was made and a peanut dissector was used to pass behind.The mesh was lifted from the vaginal well, encircled with a vessel loop, then the mesh was held with counter traction until it was able to be excised all the way to the underside of each rami and then slipped back to the other side of it.Following mesh excision, disrupted tissue planes, including the capsule from where the sling was and some bulbospongiosus, were re-approximated and reconstructed, achieving hemostasis.The vaginal wall was reconstructed, and the foley catheter remained in place.The anterior wall appeared intact, and no cystocele repair was performed, as the patient had minimal prolapse on exam.Attention was then placed to the posterior vaginal wall and rectocele repair.Allis clamps were applied distally and proximately on the posterior vaginal wall.Vasopressin was used for hydrodissection, and a 4 cm incision was made.Lateral walls vaginal epithelium was dissected off the pubocervical fascia, and the recum was reduced.Hemostasis was obtained and there was large skin blood vessels that needed to be addressed, which were superficial and near the proximal skin edge.Additionally, small air bubbles were noted, raising concern for possible rectal injury.The area was irrigated and submerged, and repeated manipulation was performed to evaluate for extraluminal air leakage.One evaluation found a small but significant arterial blood vessel bleeding and suture ligated it.Hemostasis was obtained and no further air bubbles or bleeding were observed on the rest evaluations, and no rectal injury was suspected.The earlier air was assumed from the bulb syringe or from the manipulation of a dry raytex sponge.Furthermore, the patient's right leg was noted to be displaced from the stirrup.The leg was undraped, repositioned, resecured appropriately, and the surgical team changed gowns and gloves.Sterility of the vaginal operative field was maintained throughout.The rectum was then further reduced, and the tissue edges were trimmed and reapproximated.The perineal repair was not performed due to concern for postoperative dyspareunia.Cosmetic repair was good, and the suture line remained intact.Hemostasis was adequate.The patient transferred to recovery in stable condition.The excised mesh was sent as a specimen and cystoscopic images were obtained.The patient was discharged to the pacu.She was briefly hold and monitor to concern for possible eye irritation from scratching.She remained in pacu until the eye drops were working to improve her eye discomfort.Pain had appeared to be tolerable.The patient was taught by the nurses on administration of lovenox and was discharged with a 10-day course.The patient and her spouse were counseled on the need for adequate post operation ambulation and call parameters about bleeding.The foley catheter will be removed in the office in few days.

• Brand Name: OBTRYX II TRANSOBTURATOR MID-URETHRAL SLING SYSTEM
• 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: 25167130
• Report Number: 2124215-2026-26028
• Device Sequence Number: 10524128
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: (01)08714729837565(17)210612(10)22246221
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 06/12/2021
• Device Model Number: M0068505110
• Device Catalogue Number: M0068505110
• Device Lot Number: 0022246221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 06/13/2018
• 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 Age: 48 YR
• Patient Sex: Female