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

Model Number M0068505000

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

Patient Problems Abscess (1690); Erosion (1750); Fever (1858); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Sleep Dysfunction (2517); Constipation (3274); Movement Disorder (4412); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 07/30/2020

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was used during a transobturator tape (tot) mid urethral sling placement and cystoscopy procedures performed on (b)(6) 2016 to treat a patient with stress urinary incontinence.The patient's cystoscopy after the sling placement procedure revealed normal findings.The patient was awakened from anesthesia without complication and was taken to the recovery room in good condition.On (b)(6) 2017, the patient underwent a laparoscopic repair of incisional and umbilical hernia with mesh for the preoperative diagnosis of reductible umbilical hernia and small supraumbilical incision hernia.There no complications at the conclusion of the procedure and the patient was extubated in the operating room.She was then taken to the recovery room in satisfactory condition.On (b)(6) 2020, the patient underwent an excision of bladder mesh for the preoperative diagnosis erosion of bladder mesh into the vagina.Post operatively, the patient was diagnosed with erosion of bladder mesh into the vagina with incarcerated myrtiform carunclae.Bimanual examination of the vagina revealed a sharp serrated mesh noted in the anterior vaginal vault just on the urethral meatus.The urethra was patent and was not involved in the erosion of the mesh.There was a 1 x 2 cm portion of blue serrated mesh found in the anterior vaginal wall approximately 2 cm behind the urethral meatus.During the procedure, after ensuring informed consent, the patient was brought to the operating room and placed in dorsal supine position.After adequate anesthesia was obtained, the patient was transferred to the dorsal lithotomy position, and the perineum and vagina were prepped and draped in the normal sterile fashion.The area of concern behind the urethral meatus was examined and the mesh was identified.An allis forceps was used to grab the visible portion of the mesh noted in the anterior vaginal wall.Metzenbaum scissors were then used to gently dissect the vaginal mesh away beginning on the patient's left and extending toward the right.Once all palpable portions of mesh were removed from the vaginal vault, a red rubber catheter was reinserted in the patient's urethra to ensure patency and also to ensure that the urethral meatus was uninvolved in the erosion of the vaginal mesh.The red rubber catheter was left in place while a #3-0 vicryl suture was used to close the defect in the anterior vaginal wall.It was closed from right to left with #3-0 vicryl in running locking fashion.Good hemostasis was noted throughout the procedure.A myrtiform caruncula on the posterior hymenal ring was noted to be slightly incarcerated and prominent.It was grasped with forceps and excised with metzenbaum scissors.Monopolar electrocautery was used to fulgurate the area to ensure good hemostasis.The patient tolerated the procedure well, sponge, lap, and instrument counts were correct x 2.The patient was awakened from anesthesia and transferred to the recovery room in stable condition.She was given prescriptions for toradol and instructed to follow up in the office in two weeks for post operation check.On (b)(6) 2021, the patient was seen and examined during an office visit with complaints of recurrent suprapubic abscess which has been drained twice since november.Pelvic ultrasound was done twice prior, and the abscess fluid collection was of unknown etiology.The patient had a history of diabetes mellitus, and her last a1c was unknown.The patient noticed another area of mesh erosion and she also complained of bleeding during intercourse which was bothersome and was difficult.She currently voids every two hours at daytime and once at night.She noted a change in force of strain when urinating, incontinence, dribbling, sexual difficulty, and vaginal discharge.The patient also complained of bowel irregularity and painful bowel movements or constipation.Review of systems noted that the patient reported fever and headaches, joint pain, stiffness or swelling, weakness of muscles or joints, muscle pain or cramps, back pain and had difficulty walking.Moreover, the patient also complained of depression and insomnia.Physical exam noted a midline suprapubic tangerine sized mobile lesion/mass the assessment included voiding dysfunction (retention, hesitancy and straining), history of mesh erosion with excision x 2, suprapubic abscess and bleeding with intercourse.The patient has been counseled in all the risks complication and benefits of possible therapeutic options, both medical and surgical, and desires to proceed with treatment.The patient was scheduled for a computed tomography (ct) scan for assessment of recurrent suprapubic abscess lesion.Laboratory was requested for baseline.The patient's urinary results was negative aside from glycosuria.The patient was also to continue vagifem suppositories.Due to the patient's prior complex surgical history, a plan for evaluation of anatomy and function with cystoscopy, pelvic exam and urodynamics.On (b)(6) 2021, the patient was seen for a post-op check after removal of exposed vaginal mesh and i&d of suprapubic abscess.During the surgery on an unspecified date, a very long knotted prolene suture was removed from her abdominal wall cutaneous abscess.The suture was from a previous surgery (likely hysterectomy), and she has done great since surgery.The suprapubic surgical wound has healed completely, all of the induration in this area had resolved, and she no longer had vaginal bleeding.Exam revealed the patient's vaginal area was healing nicely and there was no mesh exposure.The vicryl sutures were still in place.The suprapubic area has completely healed.There was no induration nor erythema noted.On (b)(6) 2021, the patient reported vaginal pain and bleeding after intercourse recently.She stated intercourse was very painful and she bled afterwards for a day or two.She was not currently having vaginal bleeding.She has a strong history of vaginal atrophy with vaginal bleeding in the past.This did go away with osphena, but she is no longer taking it (expense).She continued to have significant urge incontinence while taking ditropan 5 mg twice a day, and she had an accident that day which was very embarrassing to her.Exam revealed the vaginal epithelium was atrophic and fragile and bled easily with insertion of the speculum.No exposed mesh, however, some of the vicryl suture from surgery was still present.Vaginal atrophy was discussed at length.The patient agreed to start vaginal estrogen cream.The physician also discussed with the patient vaginal atrophy including the causes, typical symptoms and treatment versus observation and the correlation between this and recurrent urinary tract infections (utis).

Manufacturer Narrative

Date of event: date of event was approximated to april 20, 2021, implant date, as no event date was reported.The lot number of the suspect device provided by the complainant did not populate the system.Therefore, the manufacture and expiration dates are unknown.Initial reporter: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

• Brand Name: OBTRYX 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: 15597539
• MDR Text Key: 301680198
• Report Number: 3005099803-2022-05905
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• 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: 10/13/2022

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: M0068505000
• Device Catalogue Number: 850-500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/13/2022
• 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: 63 YR
• Patient Sex: Female