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 Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: there was no information available regarding the event date.Therefore, it was approximated to may 03, 2018, the implant date has been selected.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx ii system-halo system was implanted during a transobturator tape (tot) and cystoscopy procedure performed on (b)(6), 2018.The patient was worked up for urinary incontinence.She has mixed symptoms of urinary incontinence.However, on workup, it was identified that she had significant stress urinary incontinence.The patient did well and her symptoms were resolved at this time.After some time, the patient complained of some pain in the vagina, and also had signs indicating that she can feel something.Clinical examination showed that there was erosion of mesh in the left side of the vagina with active infection.The physician and the patient discussed the findings that this tenderness and infection is probably due to erosion of mesh or due to persistent vaginitis.They discussed that the part of the mesh need to be removed and overlying vaginal mucosa need to be closed.Also, the patient had vaginal vault prolapse and urinary incontinence.On (b)(6) 2020, the patient underwent cystoscopy and removal of vaginal mesh.Cystoscopy showed the urethra to be normal.There was no evidence of erosion of the mesh inside the urethra.The bladder neck and the bladder were patent and normal.There was no erosion inside the bladder.At this time, the cystoscope was removed.A 16-french catheter was placed and the bladder was drained out.At this point, attention was diverted to the vaginal erosion.A vaginal examination was performed, which showed a palpable sling on the left side of the vagina.Then, the patient was brought to the extended lithotomy position and trendelenburg position.A self-retaining retractor was used.The mesh was identified, and 1 % lidocaine in combination with 0.5% bupivacaine with adrenaline was used.Local anesthesia was injected into the local area.At that time, a #15 blade was used.The incision was made in a slight inverted u fashion.Then, a sharp and blunt dissection was made.The mesh was identified.Mosquitos were used and the mesh was held with mosquitos.Slowly, with metzenbaum scissors, a sharp and blunt dissection was continued.The physician was able to identify the mesh and associated inflammation on the left side going up to the mid-urethra.The physician continued to have a gentle tug on the mosquito.The mesh was able to be clearly dissected out.The first mesh was cut on the left side, and the part of the mesh was removed after cutting on the right side using metzenbaum scissors.Finally, normal saline was used.Digital examination indicated no other potential sites of erosion.Repeat cystoscopy was normal.Reportedly, the patient had recovered from anesthesia and was transferred to the recovery room in stable condition.On (b)(6) 2021, the patient had a consultation and was seen by a physician in the clinic today.She complained of some irritation, urgency, and frequency.There was no urinary incontinence or stress-related leakage of urine.She was started on oxybutin 5 mg po twice daily.Oxybutynin did help her quite significantly, but dryness of the mouth became a problem.The physician asked the patient if they could switch her to tolterodine, but she had tried it in the past and it did not work for her.She also had some lesions on her tongue, probably due to vitamin b deficiency rather than a side effect of oxybutynin.She wanted to discuss other options.The physician and the patient discussed cystoscopy and botox injections.Furthermore, she has been complaining of some vaginal discharge.This is mostly a whitish discharge and seems like a yeast infection.However, there was no bleeding in her vagina.She was given a course of fluconazole, 2 tablets.She used them, and she said it did not have any impact.She is back for further consultation.The patient also reports frequent urination.Additionally, the patient had good urinary control with no history of urinary tract infection (uti).

Event Description

It was reported to boston scientific corporation that an obtryx ii system-halo system was implanted during a transobturator tape (tot) and cystoscopy procedure performed on (b)(6) 2018.The patient was worked up for urinary incontinence.She has mixed symptoms of urinary incontinence.However, on workup, it was identified that she had significant stress urinary incontinence.The patient did well, and her symptoms were resolved at this time.After some time, the patient complained of some pain in the vagina, and also had signs indicating that she can feel something.Clinical examination showed that there was erosion of mesh in the left side of the vagina with active infection.The physician and the patient discussed the findings that this tenderness and infection is probably due to erosion of mesh or due to persistent vaginitis.They discussed that the part of the mesh needs to be removed and overlying vaginal mucosa need to be closed.Also, the patient had vaginal vault prolapse and urinary incontinence.On (b)(6) 2020, the patient underwent cystoscopy and removal of vaginal mesh.Cystoscopy showed the urethra to be normal.There was no evidence of erosion of the mesh inside the urethra.The bladder neck and the bladder were patent and normal.There was no erosion inside the bladder.At this time, the cystoscope was removed.A 16-french catheter was placed, and the bladder was drained out.At this point, attention was diverted to the vaginal erosion.A vaginal examination was performed, which showed a palpable sling on the left side of the vagina.Then, the patient was brought to the extended lithotomy position and trendelenburg position.A self-retaining retractor was used.The mesh was identified, and 1 % lidocaine in combination with 0.5% bupivacaine with adrenaline was used.Local anesthesia was injected into the local area.At that time, a #15 blade was used.The incision was made in a slight inverted u fashion.Then, a sharp and blunt dissection was made.The mesh was identified.Mosquitos were used and the mesh was held with mosquitos.Slowly, with metzenbaum scissors, a sharp and blunt dissection was continued.The physician was able to identify the mesh and associated inflammation on the left side going up to the mid-urethra.The physician continued to have a gentle tug on the mosquito.The mesh was able to be clearly dissected out.The first mesh was cut on the left side, and the part of the mesh was removed after cutting on the right side using metzenbaum scissors.Finally, normal saline was used.Digital examination indicated no other potential sites of erosion.Repeat cystoscopy was normal.Reportedly, the patient had recovered from anesthesia and was transferred to the recovery room in stable condition.On august 12, 2021, the patient had a consultation and was seen by a physician in the clinic today.She complained of some irritation, urgency, and frequency.There was no urinary incontinence or stress-related leakage of urine.She was started on oxybutin 5 mg po twice daily.Oxybutynin did help her quite significantly, but dryness of the mouth became a problem.The physician asked the patient if they could switch her to tolterodine, but she had tried it in the past and it did not work for her.She also had some lesions on her tongue, probably due to vitamin b deficiency rather than a side effect of oxybutynin.She wanted to discuss other options.The physician and the patient discussed cystoscopy and botox injections.Furthermore, she has been complaining of some vaginal discharge.This is mostly a whitish discharge and seems like a yeast infection.However, there was no bleeding in her vagina.She was given a course of fluconazole, 2 tablets.She used them, and she said it did not have any impact.She is back for further consultation.The patient also reports frequent urination.Additionally, the patient had good urinary control with no history of urinary tract infection (uti).***additional information received on february 21, 2023*** on (b)(6) 2020, the patient presented with complaints of abdominal pain and pelvic pain.She felt that her bladder sling was falling out and felt discomfort for 2 weeks.This bladder sling was placed approximately 2 years ago.The patient felt that she has had intermittent symptoms for the past month.She also thinks she had some bleeding from her vagina approximately 1 month ago but does not have it on a regular basis.The patient was able to urinate without experiencing pain when urinating.Also, there was no blood in the urine.The patient has had a hysterectomy.Furthermore, upon speculum examination, a small amount of white discharge was noted.The vaginal cuff was intact, and no bleeding was observed.There was no significant prolapse of the bladder or rectum, nor leakage of urine with valsalva.Bimanual was unremarkable.Furthermore, the patient is generally well-appearing, well-hydrated, and nontoxic.There was no life-threatening or emergent pathologic condition noted.Patient will follow-up with a urology provider in approximately 2 weeks.Earlier appointments were arranged by hospital staff prior to the patient's discharge from the er.The patient routinely uses narcotic pain medication at home.The physician and the patient discussed options for symptomatic treatment of pain.Also, they discussed warning signs that should prompt an immediate return to the emergency department.On (b)(6) 2020, the patient was seen in the clinic.She recently underwent the removal of tot mesh for erosion in the vagina and associated vaginitis.The erosion was left-sided, and the mesh was removed under all aseptic precautions.She has been doing well.She has been holding up on urinary continence.She has some symptoms of urge-related incontinence, but she had those symptoms before.On march 25, 2021, the patient was seen in the clinic for her known case of urinary incontinence and underwent tot.She later developed erosion of the mesh, and the eroded mesh was removed.She has maintained her continence since and has been doing well.Overall, she has done well.Lately, she has been complaining of excessive vaginal discharge and vaginal itching.This is mostly a whitish discharge, probably from yeast vaginitis.No bleeding per vagina.She was given a course of fluconazole 2 tablets.She used them, and she says it did not make any impact.The physician mentioned that, in case she does not respond to this treatment, she might benefit from metronidazole.She is back for further consultation.The patient had good urinary control and no history of urinary tract infection (uti).On (b)(6) 2021, the patient had her consultation, and she underwent hydrodistention and botox injection in the bladder.She has done remarkably well.She has left almost no symptoms behind.There were no symptoms suggestive of an uti or overflow incontinence.She has good continence now.

Manufacturer Narrative

Blocks a5, a6, b5, e1(attorney's address and phone number, healthcare facility address), and h6 (patient codes) were updated based on the additional information received on february 21, 2023.Block b3: there was no information available regarding the event date.Therefore, it was approximated to (b)(6) 2018, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The implant surgeon is:(b)(6) (b)(6) united states phone number: (b)(6) fax number: (b)(6) (b)(6) phone number: (b)(6)fax number: (b)(4) block h6: imdrf patient codes: e2006 captures the reportable event of extrusion (vaginal mesh erosion).E2330 captures the reportable event of pain (pain in the vagina, pelvic pain).E1002 captures the reportable event of abdominal pain.E1906 captures the reportable event of unspecified infection (persistent vaginitis).E2326 captures the reportable event of inflammation (associated inflammation on the left side going up to the mid-urethra).Imdrf impact codes: f1905 captures the reportable event of device revision or replacement (removal of eroded mesh in the vagina).F2303 captures the reportable event of medication required (oxybutin 5 mg, fluconazole, 2 tablets and narcotic pain medication, botox injection).

• 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: 15499817
• MDR Text Key: 300761455
• Report Number: 3005099803-2022-05496
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0021889878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White