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

Model Number	M0068504110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an obtryx ii system -- curved device was implanted into the patient during a laparoscopic vaginal hysterectomy, bilateral salpingo-oophorectomy, anterior and posterior colporrhaphy, enterocele repair, perineoplasty, transobturator midurethral sling, and cystourethroscopy procedure performed on (b)(6) 2018, for the treatment of symptomatic pelvic prolapse, adenomyosis, uterine leiomyomata, urethral hypermobility, and voiding dysfunction.Stage 3 pelvic prolapse, primary uterine, enlarged uterus with leiomyomata, urethral hypermobility, and benign abnormalities of both ovaries are among the surgical findings.The upper abdomen and pelvis were examined and revealed a normal bladder dome as well as a moderately enlarged, irregularly retroverted, and prolapsed uterus.A 5-mm superficial yellow lesion on the right ovary.There were no hernias in the pelvis.The retroperitoneal regions looked to be normal.A normal urethra, bladder epithelium, trigone, ureteral orifices, and bilateral ureteral efflux were discovered during a cystourethroscopy.There was no damage or injuries.Throughout the investigation, the urine remained clean.There was urethral hypermobility prior to the midurethral sling placement, as well as suprapubic pressure and a full bladder.There was obvious spilling, which was consistent with occult stress incontinence.Reportedly, the placement of the sling provided improvement in the suprapubic pressure stress test.After the procedure, the patient complained of recurrent bladder infections, vaginal pain, and pain with intercourse.The patient had vaginal graft revision, sling revision, cystocele repair, and cystoscopy on (b)(6) 2018, to address vaginal discomfort, vaginal foreign body, urine incontinence, and cystocele.A vertical incision was created from the urethral meatus to the mid-proximal anterior vaginal wall during the surgery.The inferior pubic rami on the left and right were incised.At the bladder neck, an anterior wall foreign body was discovered.It was gripped twice with the trocar, dissected out of the left and right pelvic sidewalls, excised, removed, and given to pathology.The cystocele was then plicated using 2-0 monocryl suture.A running 2-0 monocryl suture was used to seal the vertical suburethral incision.The cystocele was then plicated using 2-0 monocryl suture.A running 2-0 monocryl suture was used to close the vertical suburethral incision.The anterior vaginal mucosa was then pushed up and transversely connected, and the mucosal incision was closed transversely, raising the anterior vaginal wall and resolving the cystocele.The hemostasis was judged to be excellent.It was also reported that there was no sign of exposure or erosion of the front vaginal wall foreign body.For the safety of the lower urinary tract, a cystoscopy was further carried out.Following complete distention with normal saline, the bladder was circumferentially surveyed with the 70-degree cystoscope.Blood or a foreign object in the bladder were not found to be present.Urine immediately ejected from the left and ureteric orifices.Withdrawal also revealed the trigone and urethra to be in their natural states.The patient was administered levofloxacin and flagyl prior to the incision.By the end of the case, she had had 15 mg of toradol iv.Extubating the patient allowed for a stable state to return to the recovery area.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2017, implant procedure date, as no event date was reported.(b)(6).The explanting surgeon is: dr.(b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15387838
• Report Number: 3005099803-2022-05041
• Device Sequence Number: 12174321
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• 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): 09/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 0020492262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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
• Patient Age: 70 YR
• Patient Sex: Female