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 Material Twisted/Bent (2981)

Patient Problems Pain (1994); Urinary Retention (2119); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of february 14, 2022, was chosen as a best estimate based on the date of the mesh removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).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 received, a supplemental mdr will be filed.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that an obtryx ii system - halo and upsylon y-mesh devices were implanted into the patient during a robotic-assisted sacrocolpopexy and transobturator tape midurethral sling placement procedure performed on (b)(6) 2021 for the treatment of symptomatic total vaginal prolapse and stress urinary incontinence.Before general endotracheal anesthesia was administered, the patient was carried to the operating room and positioned in a supine posture.After a brief break, the patient was placed in the dorsal lithotomy position, prepped and draped in sterile fashion, a foley was implanted, the bladder was emptied, and a periumbilical nick was made with a 15 blade scalpel before pneumo was acquired using a veress needle.After that, all assist and robotic ports were placed under direct visualization, and the robot was docked.The anterior and posterior wings of the vagina were dissected with electrocautery and blunt dissection down to white vaginal tissue with a rommey put in the vagina canal.In a similar manner, the sacral promontory was cleansed.The y mesh was then fashioned to the right size, and x5 interrupted sutures were utilized on the ant, post, and sacral promontory to secure the graft in place and decrease prolapse.After that, the graft was retroperitonealized using a 3-0 vlock running suture, and the ports were removed under direct observation.After the ports were closed with 4-0 monocryl in a subcuticular running pattern, attention was shifted to the sling part of the case.After that, a weighted vaginal speculum before introducing 20cc of a saline/lido mix to hydro dissect the operative plane on the anterior vaginal wall and made a 3cm incision on the anterior vaginal wall, beginning 1cm proximal to the urethral meatus and continuing proximally.The surgeon used metzenbaum and blunt dissection to dissect the obturator membranes in both directions.He then performed bilateral stab incisions in the groin, lateral to the clitoral hood, and delivered to the wound using a helical trocar before attaching the sling and reversing it out the stab incision.The sling was made flush with the urethra but off tension before trimming the sheath in the other direction.The surgeon next performed an unremarkable cystoscopy before liberally irrigating the wound and running the incision with a 2-0 vicryl.The treatment was completed with the placement of vaginal packing, and the patient tolerated it well.Following the transobturator tape sling insertion, the patient developed pelvic pain, voiding dysfunction with urine retention, and a potential mesh issue.Following that, on (b)(6) 2022, the patient had to have vaginal exploration with removal of tranosobturator tape sling and transvaginal urethrolysis with cystoscopy.The preoperative results of adequate vaginal support were verified during the anesthetic examination.Around the midurethra, the sling can be felt.The sling was discovered to be in the mid-to-distal third of the urethra, not contracted anterior to the urethra; nonetheless, the sling appears to twist via the obturator musculature laterally, left side larger than right.The patient was sedated with iv medication because the procedure of removing the mesh sling arms was highly uncomfortable for her.The sling was cut in half and then split by at least 3/4 inch.Then, as desired by the patient, 2-3 cm of sling arms were removed twice and sent to pathology.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14639352
• MDR Text Key: 294840125
• Report Number: 3005099803-2022-03185
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2022

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 Model Number: M0068505110
• Device Catalogue Number: 850-511
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/08/2022
• 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: 57 YR
• Patient Sex: Female
• Patient Race: White