Obtryx™ II System - Curved M0068504110Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729839255), received between May 5, 2017 and Mar 20, 2026 — classified as 29 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX II DEVICE WAS IMPLANTED TO THE PATIENT ON (B)(6) 2019, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AFTER UNDERGOING AN INEFFECTIVE PELVIC FLOOR REHABILITATION IN 2015. FOLLOWING THE IMPLANTATION, THE PATIENT EXPERIENCED PAIN IN THE HIPS, GROIN, AND LEGS MAKING THE PATIENT UNABLE TO WALK. IT WAS REPORTED THAT SHE DECLINED FROM A PREVIOUSLY VERY ACTIVE LIFESTYLE TO A DISABLED STATE. NO MEDICAL INTERVENTIONS HAVE BEEN PERFORMED TO ADDRESS THE SYMPTOM.

  Patient problems: Pain

  MAUDE report 24654695 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX II SYSTEM - CURVED IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION TO SURROUNDING TISSUE/ORGANS, CHRONIC PELVIC PAIN, PELVIC INFLAMMATION, DYSPAREUNIA, AND VAGINAL BLEEDING. THE PATIENT SUBSEQUENTLY THE PATIENT UNDERWENT A VAGINAL MESH EXCISION SURGERY ON (B)(6) 2025. THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTED DEVICE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO ADDITIONAL SURGERY, AND MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS, SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN AND SUFFERING, MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 24337868 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX - CURVE AND UPSYLON Y-MESH FOR THE TREATMENT OF PROLAPSE AND STRESS URINARY INCONTINENCE ON A TRANSOBTURATOR TAPE SLING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE SAME PROCEDURE, PERINEORRHAPHY AND CYSTOSCOPY WERE ALSO PERFORMED. ON (B)(6) 2024, SIGMOID COLON PATHOLOGY WAS PERFORMED AND DEMONSTRATED NO SIGNIFICANT ABNORMALITY, WITH MULTIPLE DEEPER TISSUE LEVELS EXAMINED. ON (B)(6) 2024, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE WAS IDENTIFIED. ON (B)(6) 2025, THE PATIENT UNDERWENT BILATERAL SCREENING MAMMOGRAPHY, WHICH REVEALED ASYMMETRY IN THE LEFT BREAST WITH EQUIVOCAL DISTORTION AND AN ADJACENT POTENTIAL MASS. A LEFT 3-D MAMMOGRAM AND ULTRASOUND WERE RECOMMENDED FOR FURTHER EVALUATION, WHILE THE RIGHT BREAST MAMMOGRAM WAS NEGATIVE. ADDITIONAL IMAGING FINDINGS CLASSIFIED THE BREAST TISSUE AS DENSITY CATEGORY B, WITH SCATTERED FIBROGLANDULAR DENSITY. THE ASYMMETRY WITH EQUIVOCAL DISTORTION WAS NOTED IN THE MIDDLE TO POSTERIOR THIRD OF THE LEFT OUTER BREAST, LIKELY CORRESPONDING SUPERIORLY ON THE MEDIOLATERAL OBLIQUE (MLO) VIEW, AND A 5-MM POTENTIAL MASS WAS IDENTIFIED LATERAL AND SUPERIOR TO THE ASYMMETRY

  Patient problems: Abdominal Pain; Constipation; Electrolyte Imbalance; Fall; High White Blood Cell Count; Inflammation; Insufficient Information; Nausea; Necrosis; Obstruction/Occlusion; Pain; Prolapse; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Vomiting

  MAUDE report 24324987 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II TRANSOBTURATOR SLING SYSTEM - CURVED IMPLANTED DURING A SURGICAL PROCEDURE ON (B)(6) 2016, AND SUBSEQUENTLY EXPERIENCED COMPLICATIONS, INCLUDING CHRONIC LOW BACK PAIN, PELVIC PAIN AND PRESSURE, RECURRENT URINARY TRACT INFECTIONS, DYSPAREUNIA, AND VAGINAL MESH EROSION. THE PATIENT REPORTED A SIGNIFICANT DECLINE IN QUALITY OF LIFE, INCLUDING LOSS OF ENJOYMENT OF LIFE, ONGOING PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES ALLEGEDLY RELATED TO THE IMPLANTED DEVICE. ON (B)(6) 2024, THE PATIENT PRESENTED FOR EVALUATION OF LONG-STANDING COMPLICATIONS ATTRIBUTED TO THE IMPLANTED TRANSOBTURATOR SLING, INCLUDING SEVERAL YEARS OF PAINFUL VAGINAL MESH EROSION, CHRONIC PELVIC PAIN, RECURRENT URINARY TRACT INFECTIONS OCCURRING APPROXIMATELY EVERY TWO WEEKS, URINARY FREQUENCY WITH MINIMAL OUTPUT, DYSURIA, INCOMPLETE BLADDER EMPTYING, PELVIC PRESSURE, AND INABILITY TO TOLERATE PROLONGED SITTING, STANDING, OR SEXUAL INTERCOURSE. PHYSICAL EXAMINATION IDENTIFIED APPROXIMATELY 1.5 CM OF MESH EROSION ON THE RIGHT VAGINAL WALL WITH ASSOCIATED PELVIC FLOOR TENDERNESS. A DIAGNOSTIC CYSTOSCOPY PERFORMED THE SAME D

  Patient problems: Discomfort; Dyspareunia; Dysuria; Erosion; Pain; Unspecified Mental, Emotional or Behavioral Problem; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 22018586 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX II SYSTEM - CURVED IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING AN OBSTRUCTING MID-URETHRAL SLING, ABDOMINAL PAIN, PELVIC PAIN, DIFFICULTY EMPTYING THE BLADDER, DYSPAREUNIA, INFECTIONS, FURTHER OR WORSENING URINARY PROBLEMS, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abdominal Pain; Cramp(s) /Muscle Spasm(s); Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Micturition Urgency; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Retention

  MAUDE report 21915173 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION, URETHRAL AND GROIN PAIN, DYSPAREUNIA, GROIN ABSCESS, OBTURATOR ABSCESS, FURTHER OR WORSENING URINARY PROBLEMS, SEVERE SCARRING, DISFIGUREMENT, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Abscess; Deformity/ Disfigurement; Discomfort; Dyspareunia; Erosion; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 21896137 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A LYNX SYSTEM DEVICE. AS A RESULT OF THE MESH IMPLANT, THE PATIENT EXPERIENCED DYSPAREUNIA, CHRONIC ABDOMINAL AND PELVIC PAIN, EROSION, RECURRENT INFECTION, RECURRENCE OF URINARY INCONTINENCE, AND VAGINAL SCARRING. ON (B)(6) 2023, THE PATIENT HAD REVISION SURGERY OF THE IMPLANTED DEVICE. ON (B)(6) 2023, THE PATIENT UNDERWENT A SECOND REVISION/EXCISION OF THE IMPLANTED DEVICE TO RELIEVE HER EROSION AND PAIN. SHE CLAIMED TO HAVE SUFFERED SEVERE PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTATION. ADDITIONALLY, THE PATIENT MAY HAVE TO UNDERGO ADDITIONAL SURGERY IN THE FUTURE AND MAY CONTINUE TO SUFFER SIGNIFICANT PAIN, AND UNNECESSARY MEDICAL EXPENSES FOR MEDICAL CARE, TREATMENT, AND THERAPIES LONG INTO THE FUTURE. FURTHERMORE, SHE SUSTAINED AND WILL CONTINUE TO SUSTAIN IN THE FUTURE, THE FOLLOWING DAMAGES AS A RESULT OF THE IMPLANTATION: SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN, AND SUFFERING, AND HAS INCURRED ECONOMIC LOSS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Burning Sensation; Dyspareunia; Dysuria; Erosion; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 21732547 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN IMPLANTED WITH THE OBTRYX SYSTEM DEVICE. ACCORDING TO THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Abscess; Discomfort; Erosion; Insufficient Information; Unspecified Infection

  MAUDE report 20555493 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSOBTURATOR URETHRAL SLING PROCEDURE WHERE AN OBTRYX II SYSTEM - CURVED WAS IMPLANTED. DURING THE SAME PROCEDURE, CYSTOSCOPY WAS ALSO PERFORMED. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH RECURRENT INFECTIONS AND VAGINAL PAIN AFTER SLING REPLACEMENT. OPERATIVE FINDINGS REVEALED DEEP SEATED SLING CURLED TO THE LEFT SIDE. THE URETHRA WAS DISTORTED AND ELEVATED FROM THE SLING UNDERNEATH THE PROXIMAL TO MID URETHRAL REGION. THE BLADDER WAS TRABECULATED, IN GRADE FOUR, AND HAD SEVERAL AREAS OF CHRONIC CYSTITIS CYSTICA. A SMALL NARROW DEAVER WAS PLACED, WHICH ALLOWED A BETTER EXAMINATION OF THE VAGINAL WALL. THE PATIENT HAD POSTERIOR REPAIR WITH FAIRLY HIGH POSTERIOR RIDGE AND ANTERIORLY HAD A PRIOR COLPORRHAPHY SCAR. THE SLING WAS SEEN ELEVATING THE PROXIMAL URETHRA AND WAS QUITE TENTED UP. A SHORT TRANSVERSE INCISION WAS MADE AT THE LEVEL OF THE MID URETHRA, ALONG THE ANTERIOR VAGINAL WALL, AND THROUGH THAT INCISION, THE SLING WAS DISCOVERED DEEP ON THE LEFT SIDE AS NOTED ON PREOPERATIVE ULTRASOUND AND CURLED. IT WAS DIVIDED AT THE FOUR O'CLOCK POSITION AND CAREFULLY TRACKED UNDERNEATH THE URETHRA FROM LEFT TO RIGHT. AFTER THE SUBURET

  Patient problems: Deformity/ Disfigurement; Dyspareunia; Dysuria; Micturition Urgency; Pain; Scar Tissue; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Urinary Retention

  MAUDE report 19761924 ↗
• MalfunctionJun 7, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS USED DURING A SLING PROCEDURE. IT WAS NOTED THAT DURING THE PROCEDURE, THE DEVICE TWISTED AND SPLIT. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490252 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WEAS REPORTED THAT DURING AN OBTRYX LL SYSTEM - CURVED DEVICE IMPLANT PROCEDURE, THE SLING WAS BROKEN/FRACTURED. HISTORICAL EVIDENCE SUGGESTS THAT IT IS LIKELY THAT THE FRACTURE OCCURRED IN THE ASSOCIATION LOOP. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472876 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS USED DURING A TRANS OBTURATOR TAPE PLACEMENT, SACROSPINOUS LIGAMENT FIXATION, ANTERIOR AND POSTERIOR REPAIRS, PERINEORRHAPHY, AND TRANSURETHRAL CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016, FOR THE TREATMENT OF SYMPTOMATIC PELVIC ORGAN PROLAPSE AND SENSING A BULGE WITH ACTIVITY. DURING THE PROCEDURE A CYSTOSCOPY WAS PERFORMED CONFIRMING BOTH URETERS FUNCTIONED APPROPRIATELY; THERE WERE NO LESIONS OR STONES NOTED WITHIN THE BLADDER OR URETHRA. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ON (B)(6) 2022, THE PATIENT NOTED A SANDPAPER SENSATION INTERMITTENTLY, AS WELL AS HISPAREUNIA, INCREASED DISCOMFORT AND A ROUGH EDGE FELT WITH PALPATION. A CYSTOSCOPY WAS PERFORMED TO EVALUATE THE URETHRA AND BLADDER; HOWEVER, THERE WERE NO SIGNS OF MESH OR LESIONS. ADDITIONALLY, A VAGINAL EXAM DID NOT IDENTIFY EROSION SYMPTOMS OR ABNORMALITIES TO THE VAGINAL MUCOSA EITHER. THE SLING WAS PALPATED IN THE NORMAL POSITION WITH NO UNDUE TENSION. A SURGICAL PROCEDURE WAS THEN PERFORMED TO EXCISE THE VAGINAL TOT SLING MESH. A 4-CM INVERTED U-SHAPED SKIN INCISION WAS MADE ACROSS AND ERODED PORTION OF THE MESH.

  Patient problems: Chest Pain; Discomfort; Dyspareunia; Erosion; Pain

  MAUDE report 19019801 ↗
• InjuryAug 30, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS USED DURING A TRANS OBTURATOR TAPE SUSPENSION AND REPAIR OF MIDLINE DEFECT ON THE ANTERIOR VAGINAL WALL PROCEDURE PERFORMED ON (B)(6) 2021, FOR THE TREATMENT OF RECURRENT STRESS URINARY INCONTINENCE AND MIDLINE CYSTOCELE. DUE TO RECURRENT STRESS URINARY INCONTINENCE AND A MIDLINE CYSTOCELE, THE PATIENT HAD TRANS OBTURATOR TAPE SUSPENSION AND REPAIR OF A MIDLINE DEFECT ON THE ANTERIOR VAGINAL WALL ON (B)(6) 2021. THE PREVIOUSLY PLACED TRANS OBTURATOR TAPE HAD MOVED PROXIMALLY AND WAS NO LONGER BENEATH THE MID-SEGMENT OF THE URETHRA. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH A STRING OF RECURRENT INFECTIONS NOT RESPONDING TO ANTIBIOTIC TREATMENT AND FOUND OBSTRUCTED BY A PROXIMAL SLING AFTER PRIOR SLING PLACEMENT AND REVISION. SHE WAS ALSO FOUND TO HAVE CHRONIC CYSTITIS CYSTICA AND DYSPAREUNIA. THE PATIENT THEN UNDERWENT CYSTOSCOPY, SUB URETHRAL SLING RELEASE, AND FULGURATION OF STAGE 2 CHRONIC CYSTITIS. CYSTOSCOPY REVEALED A VERY NARROW PROXIMAL URETHRA FROM THE SLING PLACED IN THE LOCATION. ADDITIONALLY, A CHRONIC CYSTITIS CYSTICA OVER THE TRIGONE AND BLADDER BASE WAS FOUND. THE SLING

  Patient problems: Dyspareunia; Stenosis; Urinary Retention; Urinary Tract Infection

  MAUDE report 17654139 ↗
• MalfunctionJun 1, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS USED DURING A TRANSOBTURATOR SLING PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE DEVICE. SHE KEPT HITTING SOMETHING THAT WOULD NOT ALLOW HER TO ADVANCE THE DEVICE. SHE TRIED TO TROUBLESHOOT IN SEVERAL DIFFERENT WAYS, ULTIMATELY BELIEVING THAT THE PATIENT'S ANATOMY WOULD NOT ALLOW FOR THE CURVED NEEDLE TO GET AROUND THE PATIENT'S PUBIC BONE. THE PROCEDURE WAS CANCELLED, AND THE PATIENT HAS BEEN REFERRED TO A DIFFERENT PHYSICIAN (A UROGYNECOLOGIST SPECIALIST).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038534 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR VAGINAL WALL REPAIR, TRANSOBTURATOR MID-URETHRAL SLING PLACEMENT AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2015 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE, MIDLINE CYSTOCELE AND HYPERMOBILITY OF URETHRA. THE PROCEDURES' FINDINGS ARE AS FOLLOWS: CYSTOCELE OF THE MIDLINE, GRADE 3. THE BLADDER MUCOSA AND URETHRA WERE FOUND TO BE NORMAL APPEARING, WITH NO INDICATION OF DAMAGE. THE PATIENT WAS WOKEN AND BROUGHT TO THE RECOVERY ROOM IN A STABLE AND SATISFACTORY POSTOPERATIVE CONDITION. ACCORDING TO REPORTS, THE PATIENT HAD PELVIC PAIN AND A SMALL PELVIC HEMATOMA. ON (B)(6) 2016, THE PATIENT UNDERWENT A MID-URETHRAL SLING REVISION, EVACUATION OF A SMALL PELVIC HEMATOMA, AND CYSTOSCOPY. DURING THE PROCEDURE, A VERTICAL INCISION WAS MADE THROUGH THE FULL THICKNESS OF THE VAGINAL WALL BETWEEN THE TWO ALLIS CLAMPS. THE VAGINAL MUCOSA WAS SEPARATED FROM THE UNDERLYING FASCIA USING METZENBAUM SCISSORS. THE PERIURETHRAL SPACES WERE THEN DISSECTED FURTHER WITH METZENBAUM SCISSORS. THE RIGHT PERIURETHRAL AREA WAS FILLED WITH OLD BLOOD. THEN, THOROUGH

  Patient problems: Adhesion(s); Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 16094492 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A MID-URETHRAL SLING AND CYSTOSCOPY PROCEDURE PERFORMED ON SEPTEMBER 2, 2016 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. AT THE END OF THE CYSTOSCOPY, THERE WAS NO SIGN OF A TUMOR, CARCINOMA IN SITU, STONES, OR FOREIGN BODIES IN THE BLADDER. THE URETERAL ORIFICES WERE IN THEIR USUAL ANATOMIC LOCATION, AND CLEAR URINE WAS EFFLUXING BILATERALLY. THE URETHRA WAS NORMAL. THERE WERE NO COMPLICATIONS. THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT, AND SHE WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION.ON JUNE 25, 2017, THE PATIENT STATES THAT SHE WAS DIAGNOSED WITH RECTAL PROLAPSE IN 2015 BUT FORGOT ABOUT IT BECAUSE SHE UNDERWENT RECTOCELE REPAIR IN SEPTEMBER 2015, HOWEVER SHE MISTOOK THE RECTAL PROLAPSE FOR THE RECTOCELE SURGERY AND THOUGHT IT WAS GONE. THE PATIENT ALSO HAD A POSTERIOR REPAIR WITH ANAL SPHINCTEROPLASTY IN 2004 AND REPORTS NO STOOL LEAKAGE BEFORE OR AFTER THE SURGERY. IN 2008, SHE HAD A SUPRACERVICAL HYSTERECTOMY FOR FIBROIDS, AND IN 2015, SHE HAD A ROBOTIC SACROCOLPOPEXY FOR PROLAPSE. SHE HAD A TRANSOBTURATOR SLING PLACED FOR INCO

  Patient problems: Abdominal Pain; Adhesion(s); Depression; Discomfort; Dyspareunia; Dysuria; Fatigue; Heartburn/Indigestion; High Blood Pressure/ Hypertension; Inflammation; Micturition Urgency; Nerve Damage; Neuropathy; Numbness; Pain; Prolapse; Swelling/ Edema; Unspecified Kidney or Urinary Problem; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 15508556 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. THER

  Patient problems: Dyspareunia; Erosion; Pain; Prolapse; Unspecified Infection; Urinary Incontinence

  MAUDE report 15387838 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OBTRYX II SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT ACQUIRED AN MRSA (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS) INFECTION AFTER THE MESH WAS IMPLANTED. THE PATIENT HAD TO HAVE THE MESH REMOVED AS A RESULT OF THE CONDITION.

  Patient problems: Bacterial Infection

  MAUDE report 14739739 ↗
• InjuryJun 13, 2022Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED EROSION OF THE MESH THROUGH HER VAGINAL WALL, DAMAGE TO THE PATIENT'S NERVES, AND SEVERE ADVERSE REACTIONS TO THE MESH INCLUDING SCARRING AND INFLAMMATION. THE PATIENT, AS A RESULT OF THESE DEFECTS AND THE PROBLEM WITH THE OBTRYX II, HAS IN THE PAST AND WILL IN THE FUTURE SUFFER FROM DISFIGUREMENT, CHRONIC PAIN, DISABILITY, CONTINUED URINARY PROBLEMS, THE COST OF THE SURGERY TO REMOVE THE MESH AND REPAIR THE VAGINAL DEFECT, AS WELL AS PAIN, INCONVENIENCE, EMOTIONAL DISTRESS AND POTENTIAL OR PROBABLE FUTURE PROCEDURES, MEDICATIONS, AND MEDICAL TREATMENT. ON (B)(6) 2020, THE MESH WAS THEN EXPLANTED.

  Patient problems: Anxiety; Deformity/ Disfigurement; Depression; Diarrhea; Dyspareunia; Dyspnea; Erosion; Fecal Incontinence; Inflammation; Micturition Urgency; Nerve Damage; Numbness; Pain; Perforation; Prolapse; Scar Tissue; Sleep Dysfunction; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 14676155 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MIDURETHRAL SLING SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING CYSTOSCOPY WITH FULGURATION OF HEMANGIOMA + TRANSOBTURATOR SLING PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019 FOR THE TREATMENT OF STRESS INCONTINENCE, BLADDER HEMANGIOMA AND MICROSCOPIC HEMATURIA. AFTER THE IMPLANT, IT WAS REPORTED THAT THE PATIENT HAD MESH EROSION. ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL SURGERY OF EXPOSED MESH. AFTER THE REMOVAL, PALPATION WAS CAREFULLY DONE AND THERE WAS NO EVIDENCE OF ANY RESIDUAL OR EXPOSED SLING AND NO IMMEDIATE POSTOPERATIVE COMPLICATIONS.

  Patient problems: Erosion

  MAUDE report 13933162 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THREE DEVICES IMPLANTED INTO THE PATIENT DURING THE SAME PROCEDURE, OBTRYX II SYSTEM - CURVED. PLEASE REFER TO MFR REPORT 3005099803-2022-01320, 3005099803-2022-01321, 3005099803-2022-05509 FOR THE ASSOCIATED DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED, UPHOLD LITE AND GRAFT MATERIALS - XENFORM DEVICE WERE IMPLANTED INTO THE PATIENT DURING A CYSTOCELE REPAIR WITH UPHOLD GRAFT, BILATERAL SACROSPINOUS LIGAMENT VAGINAL VAULT SUSPENSION, RECTOCELE AND ENTEROCELE REPAIR WITH 6X10 XENFORM GRAFT, TRANSOBTURATOR TAPE SLING PLACEMENT, CYSTOSCOPY AND PERINEOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE, SYMPTOMATIC RECTOCELE AND CYSTOCELE, STRESS URINARY INCONTINENCE, UTEROVAGINAL PROLAPSE, AND LARGE ENTEROCELE. REPORTEDLY, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN A NORMAL, STABLE MANNER. THE PATIENT COMPLAINS OF VAGINAL PAIN AT THE INTROITUS FOLLOWING THE PROCEDURE. IT'S "CRAMPY," SHE SAYS. BECAUSE OF THE PROLAPSE, SHE IS UNABLE TO ENGAGE IN SEXUAL ACTIVITY. SHE ALSO CLAIMS THAT THE PAIN HAS BEEN PRESENT FOR OVER A YEAR AND THAT SHE DOES NOT HAV

  Patient problems: Burning Sensation; Depression; Discomfort; Dyspareunia; Erosion; Insufficient Information; Micturition Urgency; Nerve Damage; Pain; Prolapse; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 13786994 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOT PLACEMENT WITH CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017 FOR THE TREATMENT OF STRESS INCONTINENCE. ON (B)(6) 2020, THE PATIENT PRESENTED FOR PROLAPSE VAGINAL BULGE. FOLLOWING THE SLING PLACEMENT, THE PATIENT HAD WORSENING OF OVERACTIVE BLADDER AND URINARY RETENTION THAT IMPROVED FOLLOWING INTERSTIM. UDS URODYNAMIC STUDY PERFORMED ON AN UNKNOWN DATE SHOWED DELAYED SENSATION, NO ELEVATED VOIDING PRESSURE, OR DETRUSOR OVERACTIVITY, AND NO STRESS INCONTINENCE, BUT THE PATIENT REPORTED SYMPTOMS OF URGENCY, URGE INCONTINENCE, STRESS INCONTINENCE, FREQUENCY, NOCTURIA, OBSTRUCTIVE SYMPTOMS WITH STRAINING TROUBLE URINATING AND FEELING OF INCOMPLETE EMPTYING, RECURRENT URINARY TRACT INFECTIONS UTIS, AND CONSTIPATION. THE PATIENT ALSO HAD VAGINAL MESH EXPOSURE THAT HAD NOT RESPONDED TO ESTRACE TREATMENT STARTED ONE MONTH PRIOR. SHE EXPERIENCED DYSPAREUNIA. POSSIBLE EXCISION OF SLING WAS DISCUSSED. AN OFFICE VISIT ON (B)(6) 2020 REPORTED ONGOING OAB, STRAINING TO VOID, DYSPAREUNIA, AND VAGINAL DISCHARGE. EXAM REVEALED A 2CM SLING EROSION IN THE LEFT LATERAL

  Patient problems: Abnormal Vaginal Discharge; Constipation; Cramp(s) /Muscle Spasm(s); Discomfort; Dyspareunia; Dysuria; Erosion; Insufficient Information; Micturition Urgency; Numbness; Obstruction/Occlusion; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 12774902 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH PELVIC PAIN, DYSMENORRHEA, DYSPAREUNIA AND STRESS URINARY INCONTINENCE. ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM DURING A TOTAL ROBOTIC HYSTERECTOMY, BILATERAL SALPINGECTOMY AND AN OBTRYX II TRANSOBTURATOR SLING PROCEDURE. THE PATIENT WENT FOR AN OUTPATIENT VISIT TO THE HOSPITAL ON (B)(6) 2017. ACCORDING THE PATIENT, SHE HAD EXPERIENCED 3 DAYS OF INTERMITTENT FLANK PAIN WITH NAUSEA AND VOMITING. REPORTEDLY, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY SCAN PROCEDURE AND A 3MM PROXIMAL LEFT URETERAL STONE WITH OBSTRUCTION WAS NOTED. SUBSEQUENTLY, THE PATIENT WAS ADVISED TO UNDERGO A CYSTOSCOPY, LEFT RETROGRADE AND LEFT URETERAL STENT PLACEMENT ON (B)(6) 2017, THE PATIENT WENT FOR AN OUTPATIENT VISIT WITH AN ADMITTING DIAGNOSIS OF CALCULUS OF URETER. DURING THE FLAT PLATE ABDOMEN X-RAY, A MINIMAL RIGHT NEPHROLITHIASIS AND NUMEROUS PHLEBOLITHS OVERLYING THE PELVIS WAS NOTED. ON (B)(6) 2018, THE PATIENT WENT FOR AN OUTPATIENT VISIT WITH MULTIPLE CHIEF COMPLAINTS. THE PATIENT REPORTS THAT SHE HAD EXPERIENCED A PAIN ON HER ABDOMEN WITH NAUSEA AND VO

  Patient problems: Dysuria; Hematuria; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 12376615 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED ON THE SAME PATIENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SLING SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH ADVANTAGE FIT BLUE SYSTEM. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Erosion; Insufficient Information; Pain; Prolapse; Scar Tissue; Urinary Incontinence

  MAUDE report 12121044 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH STRESS URINARY INCONTINENCE. ON (B)(6) 2018, SHE WAS IMPLANTED WITH AN OBTRYX II SYSTEM - CURVED DEVICE DURING A PLACEMENT OF TRANSOBTURATOR SLING & CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH HEMATURIA AND PASSAGE OF CLOTS FROM HER VAGINA. PELVIC EXAM REVEALED A CLOT IN THE VAGINA THAT DRAINED THROUGH THE VAGINAL INCISION AND HAD CAUSED THE SEPARATION OF THE INCISION, EXPOSING THE MESH. SHE UNDERWENT VAGINAL WASHOUT AND CLOSURE PROCEDURE OF VAGINAL LACERATION. THERE WAS NO ACTIVE BLEEDING NOTED DURING THE PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTEDLY HAD MULTIPLE VISITS TO THE ER (EMERGENCY ROOM) FOR VAGINAL PAIN AND WAS COMPLAINING OF FEELING THE MESH. A PELVIC EXAM WAS DONE WITH THE ER (EMERGENCY ROOM) AND DOCTORS DID NOT REVEAL ANY MESH EXTRUSION. SHE UNDERWENT ONE PELVIC EXAM BY HER IMPLANTING SURGEON AND IT ALSO REVEALED NORMAL. HOWEVER, HER PAIN GOT WORSE AND SHE WANTED THE SLING OUT BECAUSE SHE WAS FEELING IT. AFTER REVIEWING ALL THE RISKS ASSOCIATED WITH THE PROCEDURE, THE

  Patient problems: Erosion; Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain; Wound Dehiscence

  MAUDE report 11408972 ↗