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

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the mesh was implanted.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6) hospital.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2101 - adhesions.E2330 - pain.E1405 - dyspareunia.E1715 - scar tissue.E1301 - dysuria.E1309 - urinary retention.E1310 - urinary tract infection.E2326 - inflammation.E2015 - atrophy.E020202 - depression.E020201 - anxiety.The following imdrf impact code capture the reportable event of: f203 - medications prescribed to the patient.F1901 - additional surgeries.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during anterior and posterior repair, transobturator sling placement, and cystoscopy procedure performed on (b)(6) 2019 for the treatment of pelvic pain, stress incontinence, cystocele, and rectocele.During the procedure, it was determined that the uterus was normal in size and mobile, with an anteverted position.There were no indications of prolapse or adnexal masses, and both the uterus and cervix were well-supported.An examination with a speculum revealed a normal cervix, while a grade 2 cystocele and rectocele were identified upon further observation.The procedure was well-tolerated by the patient and they were transported to the post anesthesia care unit in a stable condition.The patient experienced various symptoms on (b)(6) 2019, including nausea, vomiting, diarrhea, abdominal pain, and cramping.In addition, symptoms of dysuria, frequency, and urinary tract infection were reported.The patient also feels sore all over but worse in her abdomen, and streaks of blood were noticed in her vomit, according to the report.The following medications were given to the patient: pyridium (phenazopyridine) 200mg tablets.Ditropan (oxybutynin) 5 mg tablets.Phenergan (promethazine) 25 mg tablets.On (b)(6) 2019, a patient was admitted to the hospital due to drowsiness and decreased alertness that had been occurring for a few hours.The patient was seen in the emergency room and diagnosed with a mild urinary tract infection.The doctor prescribed bactrim, but the patient later reported feeling dizzy and lightheaded, which they suspected could be attributed to the medication.The patient did not experience any fever, chills, nausea, or vomiting.However, the patient began to feel drowsy and obtunded at home, and her husband could not keep her awake.Upon inspection, it was observed that the patient had all her medication with her except for 1 or 2 tablets of phenergan and buspar, which were missing.The husband was unsure if the patient had taken any recreational drugs but noted that it was not something they typically did.No evidence of falls, head trauma, seizures, or tonic-clonic activity was found in the patient's medical history.When the patient was first evaluated in the emergency room, she appeared drowsy and was snoring loudly, but no signs of respiratory depression were observed.Despite receiving two doses of narcan to address their pinpoint pupils, the patient showed no improvement.A ct scan of the brain was conducted, which did not reveal any acute abnormalities.As a precaution, the patient was referred to the hospitalist service for observation, as she may require time to recover from the effects of a designer recreational sedative that was not detected on her urine drug screen.The patient received multiple medical procedures on (b)(6) 2021 to treat several health issues.These procedures included diagnostic laparoscopy, laparoscopic lysis of adhesions, revision of anterior colporrhaphy, excision of vaginal scar tissue, and cystoscopy with hydrodistension and bladder instillation.These procedures aimed to alleviate the patient's symptoms of pelvic pain, dyspareunia, symptomatic cystocele, and stress urinary incontinence.The patient has reported that her pelvic pain has worsened over the past few years and has become even more severe in the past few months.She also experiences symptomatic cystocele, stress urinary incontinence, anxiety and depression.The pain has significantly affected the patient's quality of life and has even led to abstinence from sexual activity due to dyspareunia.Moreover, during the course of the anesthesia exam, it was ascertained that the patient had previously undergone surgery resulting in the absence of the uterus and cervix, as well as both ovaries.The vaginal lining was consistent with surgical menopause and there was evidence of scar tissue from a previous anterior colporrhaphy repair.Additionally, a grade 2 cystocele was noted.The vaginal cuff was found to be intact and mobile, and there was no indication of endometriosis.Laparoscopic findings revealed omental adhesions adherent to the anterior abdominal wall, but no bowel involvement.The upper abdomen appeared normal, with no discernible abnormalities identified in the liver, gallbladder, or appendix.A cystoscopy was performed, which revealed an inflamed bladder with diminished capacity, consistent with interstitial cystitis based on operative findings and the patient's medical history.Hydrodistension exposed trabeculations and petechial hemorrhages.Furthermore, the patient tolerated the procedure well and was transported to the recovery room in stable condition.On (b)(6) 2021, the patient reported experiencing dysuria, hematuria, retention of urine, and lower abdominal pain.The patient mentioned having undergone surgery for urinary incontinence recently.However, the surgery was not successful, and another surgery was performed 12 days ago.Unfortunately, the patient was unable to urinate after the second surgery, which led to the placement of a catheter.The patient has been on suppressive antibiotics, but she has been out of them for several days now.Additionally, she has run out of her pain medication.The patient is complaining of suprapubic pain and has experienced new-onset hematuria in the past two days.She denies experiencing fever, chills, nausea, vomiting, or diarrhea.She also denies having any back pain.As per the report, the patient underwent a pelvic exam with a gynecological surgeon, which did not reveal any concerns.The surgeon administered 250cc of normal saline to irrigate the patient's catheter, resulting in a much lower residual as compared to the previous measurements.The surgeon prescribed pain medication and advised the patient to follow up as scheduled, in case of a possible urinary tract infection.Additionally, the patient received guidelines on how to return sooner than their scheduled appointment, if required, with her physician.

• Brand Name: OBTRYX SYSTEM
• 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: 17359906
• MDR Text Key: 319387015
• Report Number: 3005099803-2023-03906
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• 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: 34 YR
• Patient Sex: Female