Obtryx™ System - Curved M0068504000Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 08714729718963), received between Nov 21, 2017 and Oct 28, 2025 — classified as 99 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (6 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 102 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MESH BROKE OFF BOTH SIDES OF THE HANDLE. THIS MOST LIKELY INDICATES THAT THE MESH ASSOCIATION LOOPS, WHICH CONNECT THE MESH TO THE DELIVERY DEVICE NEEDLES, DETACHED OR BROKE FROM THE NEEDLES DURING USE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405754 ↗
• InjuryMay 30, 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 ABNORMAL VAGINAL BLEEDING (SUCH AS POST-COITAL BLEEDING), HEMATURIA, VAGINAL DISCHARGE, DYSPAREUNIA, URINARY FREQUENCY, EXPOSURE/EROSION OF VAGINAL MESH, SCARRING, AND PAIN (INCLUDING URETHRAL TENDERNESS). THE PATIENT SUBSEQUENTLY UNDERWENT A REMOVAL OF EXPOSED VAGINAL MESH AND CYSTOURETHROSCOPY. DURING THE PROCEDURE, AN AREA OF GRANULATION TISSUE WITH LOW-GRADE BLEEDING WAS NOTED TO THE RIGHT OF THE MIDLINE AT THE LEVEL OF THE MID-URETHRAL SLING. A MIDLINE VAGINAL INCISION WAS MADE BENEATH THE MID-URETHRA. THE MESH WAS IDENTIFIED AND TRACED TO THE AREA OF EXPOSURE. DISSECTION CONTINUED TO THE LEFT, WHERE THE MESH WAS FOLLOWED TO THE INFERIOR PUBIC RAMI AND DETACHED. ON THE RIGHT SIDE, THE MESH WAS NOT CLEARLY VISIBLE, AND REMOVAL EXTENDED ONLY SLIGHTLY PAST THE MIDLINE. IT WAS NOTED THAT THE REMAINING MESH MAY HAVE BEEN PREVIOUSLY REMOVED OR DETACHED DURING DISSECTION. HEMOSTASIS WAS CONFIRMED. CYSTOSCOPY WAS PERFORMED AT THE CONCLUSION OF THE PROCEDURE, REVEALING NO TRAUMA OR MESH EXPOSURE IN THE BLADDER OR URETHRA. NORMAL PERISTALTIC FLOW OF CLEAR

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Dyspareunia; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 22118629 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME AFTER IMPLANTATION, THE PATIENT WAS SEEN BY A UROLOGIST DUE TO EXPERIENCED PERSISTENT INCONTINENCE. DURING BULKAMID TREATMENT, URETHRAL EROSION OF THE SLING WAS IDENTIFIED. NO PAIN WAS NOTED IN THE THIGH ROOTS OR OBTURATOR FORAMEN. GIVEN THE EROSION, COMPLETE REMOVAL OF THE SLING WAS INDICATED AS THE FIRST STEP IN MANAGEMENT. ON (B)(6) 2025, UNDER GENERAL ANESTHESIA, THE ERODED MESH WAS SUCCESSFULLY REMOVED VIA VAGINAL ACCESS, AND THE PATIENT HAS BEEN FEELING MUCH BETTER.

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 22004004 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH THIS OBTRYX SYSTEM EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Discomfort; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 21355880 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX SYSTEM - CURVED AND UPHOLD LITE. AS A RESULT OF THE MESH IMPLANT, THE PATIENT EXPERIENCED EROSION OF THE MESH TO THE URETHRA, FREQUENT URINARY TRACT INFECTIONS, PURULENT VAGINAL DISCHARGE, PELVIC PAIN, AND DYSPAREUNIA. ON (B)(6) 2023, THE PATIENT UNDERWENT MESH REVISION SURGERY. 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. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES IMPLANTED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2024-74954 FOR THE OBTRYX SYSTEM - CURVED DEVICE, AND 2124215-2024-74964 FOR UPHOLD LITE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Chest Pain; Constipation; Dyspareunia; Dyspnea; Dysuria; Erosion; Fecal Incontinence; Micturition Urgency; Pain; Prolapse; Rash; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 20805510 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE PROCEDURE, THE PATIENT HAD NO MORE BOWEL MOVEMENT (MANDATORY PURGING). THE ABDOMINAL PAIN, WHICH WAS MORE PRONOUNCED ON THE LEFT SIDE, URINARY INFECTIONS, AND PERI-UTERINE THROMBOSIS WERE RECURRENT. THE PATIENT IS CURRENTLY EXPERIENCING PAIN, FATIGUE, AND INABILITY TO DEFECATE. SHE IS CURRENTLY TAKING ANTIBIOTICS AND CAN NO LONGER STAND OR SIT FOR A LONG TIME, AND HAS CRURALGIA. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES IMPLANTED IN SEPARATE PROCEDURES.

  Patient problems: Constipation; Fatigue; Pain; Thrombosis/Thrombus; Urinary Tract Infection

  MAUDE report 20433057 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS OBTRYX SYSTEM EXPERIENCED COMPLICATIONS, INCLUDING EROSION OF THE MESH, SEVERE AND CHRONIC PAIN, INCLUDING LOW BACK PAIN, FURTHER AND PERSISTENT URINARY PROBLEMS, RECURRENT INFECTIONS, SCARRING, AND A LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMED TO HAVE 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: Erosion; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20185866 ↗
• InjuryJul 22, 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 TAPE MID-URETHRAL SLING IMPLANT PROCEDURE PERFORMED ON (B)(6) 2019. DURING THE SAME SURGERY, AN ABDOMINAL SACRAL COLPOPEXY, HALBAN'S CULDOPLASTY, RIGHT SALPINGO-OOPHORECTOMY, AND CYSTOCELE REPAIR PROCEDURE WERE ALSO PERFORMED. IT WAS NOTED THAT FOLLOWING THIS PROCEDURE, THE PATIENT EXPERIENCED DYSPAREUNIA, SEVERE PAIN INCLUDING ABDOMINAL PAIN, SCARRING, FURTHER URINARY PROBLEMS, RECURRENT MESH EROSION, DISCHARGE, AND LOSS OF ENJOYMENT OF LIFE. ON (B)(6) 2023, THE PATIENT WAS EXPERIENCING AGAIN DYSPAREUNIA AND MESH EROSION; THEREFORE, AN EXCISION OF THE TRANSVAGINAL TENSION-FREE TAPE WAS PERFORMED. A CYSTOURETHROSCOPY WAS PERFORMED, REVEALING NO LESIONS, STITCHES, OR TRAUMA TO THE BLADDER. A PURPLE MESH WAS FOUND UNDER THE URETHRA AND IN A TIGHT BAND. DURING THE PROCEDURE, THE PATIENT WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS AND PNEUMATIC COMPRESSION STOCKINGS WERE APPLIED BILATERALLY. A VAGINAL EXAM WAS PERFORMED, CONFIRMING THE MESH EROSION. SUBSEQUENTLY, AN INVERTED U INCISION WAS MADE IN THE VAGINAL EPITHELIUM UNDERLYING THE MID URETHRA. THE MESH WAS IDENTIFIED VISUALLY AND BY PALPATION. ALLIS CLAMPS WERE USED TO GRASP

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Discomfort; Dyspareunia; Erosion; Fibrosis; Pain; Prolapse; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 19795690 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX SYSTEM-CURVED DEVICE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. DUE TO THE IMPLANTATION, THE PATIENT EXPERIENCED SEVERE DYSPAREUNIA, STRESS URINARY INCONTINENCE, OVERACTIVE BLADDER, MESH EXTRUSION, BLADDER IRRITATION, PELVIC PAIN, UTEROVAGINAL PROLAPSE, AND HEAVY VAGINAL BLEEDING.

  Patient problems: Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Pain; Prolapse; Skin Inflammation/ Irritation; Urinary Incontinence

  MAUDE report 19470411 ↗
• InjuryApr 12, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. IT WAS NOTED THAT THE PAIN WAS FELT IN THE ABDOMEN, GENITALS, GROIN, LOWER BACK, PERINEUM, AND THIGHS. ADDITIONALLY, SYMPTOMS OF BURNING SENSATION, SLEEP PROBLEMS, FATIGUE, LOSS OF BALANCE, MUSCLE WEAKNESS, POLLAKIURIA, URINARY AND FECAL LEAKAGES, CONSTIPATION, AND PROLAPSE WERE REPORTED. IT WAS INDICATED THAT THE PATIENT PRESENTED DIFFICULTIES DURING PROLONGED WALKING, PROLONGED SITTING, AND DURING CERTAIN MOVEMENTS SUCH AS PRACTICING SPORTS, OR DURING INTIMATE RELATIONSHIPS. THEREFORE, THE PATIENT NOTED THEIR DAILY LIFE HAD BEEN COMPROMISED. IT WAS DETAILED THAT AN EXPLANT DATE WAS PERFORMED ON MAY 05, 2021. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE LOCATION AND PATIENT OUTCOME TO DATE.

  Patient problems: Abdominal Pain; Balance Problems; Burning Sensation; Constipation; Fatigue; Fecal Incontinence; Muscle Weakness/Atrophy; Pain; Prolapse; Sleep Dysfunction; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 19101471 ↗
• InjuryMar 11, 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 SYSTEM - CURVED WAS IMPLANTED INTO THE PATIENT DURING A TENSION-FREE VAGINAL TAPE OBTURATOR SLING PROCEDURE PERFORMED ON (B)(6) 2012, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. CYSTOSCOPY WAS PERFORMED AND SHOWED NO BLADDER INJURY. THE PATIENT WAS IN STABLE AND GOOD CONDITION. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH EROSION OF BLADDER SUSPENSION MESH AND VAGINAL DISCHARGE. DURING SURGERY, ALLIS CLAMPS WERE USED TO GRASP THE VAGINAL EPITHELIUM ON EITHER SIDE OF THE EXPOSED MESH. A TONSIL WAS PLACED BETWEEN THE URETHRA AND THE EXPOSED MESH. THE APPROXIMATELY ONE AND A HALF CENTIMETERS AREA OF MESH WAS EXCISED SHARPLY WITH METZENBAUM SCISSORS. CYSTOURETHROSCOPY WAS COMPLETED, IDENTIFYING THERE WAS MILD BLADDER TRABECULATIONS PRESENT; OTHERWISE, THE BLADDER WAS NORMAL. THE URETHRAL MUCOSAS WITH EFFLUX OF URINE WERE NOTED FROM EACH URETERAL ORIFICE. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION.

  Patient problems: Abnormal Vaginal Discharge; Dyspareunia; Erosion; Insufficient Information; Localized Skin Lesion; Micturition Urgency; Pain; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 18882385 ↗
• InjuryFeb 28, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - CURVED WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. IT WAS REPORTED THAT THE SLING WAS TOO TIGHT CAUSING A FOLD ON THE URETHRA. THE PATIENT CURRENT STATE INCLUDED POOR EMPTYING OF THE BLADDER, RESIDUE, URINARY TRACT INFECTIONS, PYELONEPHRITIS, OVERACTIVE BLADDER, URGES, BLADDER SPASMS, ELECTRIC SHOCKS IN THE BLADDER, PSYCHOLOGICAL TRAUMA, LOSS OF CONFIDENCE, AND STRESS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Inflammation; Micturition Urgency; Pain; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 18796787 ↗
• MalfunctionNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - CURVED WAS USED DURING A TRANSOBTURATOR MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NEEDLE THROUGH THE OBTURATOR MEMBRANE AND VAGINAL INCISION. A LOOP WAS ATTACHED TO THE DISTAL END OF THE NEEDLE AND PULLED BACK THE NEEDLE THROUGH THE SKIN; HOWEVER, THE BLUE DILATOR CAME LOOSE FROM THE MESH ASSEMBLY. THEY MANAGED TO GRAB THE MESH AND PULL IT THROUGH THE SKIN. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209113 ↗
• InjuryOct 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 SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL VAGINAL HYSTERECTOMY, ANTERIOR AND POSTERIOR COLPORRHAPHY, MID-URETHRAL TRANS-OBTURATOR SLING, AND CYSTOSCOPY PROCEDURE ON (B)(6) 2011, FOR THE TREATMENT OF SYMPTOMATIC PELVIC PROLAPSE AND STRESS URINARY INCONTINENCE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2022, THE PATIENT WAS ADMITTED AND WAS FOUND TO HAVE A BLADDER STONE ON CROSS-SECTIONAL IMAGING. A CYSTOSCOPY PROCEDURE WAS PERFORMED AND REVEALED BLADDER STONE GREATER THAN 2.5 CM ADHERENT TO THE ERODED MESH ON THE RIGHT BLADDER NECK. A 270-MICRON HOLMIUM LASER FIBER WAS USED TO BREAK ALL THE STONE AND ASPIRATE OUT ALL OF THE FRAGMENTS. SUBSEQUENTLY, THE DOME OF THE BLADDER WAS VISUALIZED, AND A 5MM LAPAROSCOPIC TROCAR WAS PLACED EXTRA PERITONEALLY ABOVE THE PUBIC BONE INTO THE BLADDER UNDER DIRECT VISUALIZATION. THE INNER CANNULA WAS REMOVED, AND A LAPAROSCOPIC DEBAKEY GRASPER WAS INSERTED THROUGH THE PORT SITE INTO THE URINARY BLADDER. THE DEVICE WAS EXCHANGED FOR A 70-DEGREE LENS, AND THE MESH EROSION ON THE BLADDER WALL WAS EXAMINED. TH

  Patient problems: Erosion; Obstruction/Occlusion

  MAUDE report 17868412 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE THIRD OF THREE DEVICES USED IN SEPARATE PROCEDURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM DEVICE WAS IMPLANTED DURING AN ANTERIOR COLPORRHAPHY AND SACROSPINOUS LIGAMENT FIXATION, PARAVAGINAL DEFECT REPAIR WITH UPHOLD, VIDEO CYSTOSCOPY, AND POSTERIOR COLPORRHAPHY IN TRADITIONAL FASHION PROCEDURE PERFORMED ON (B)(6) 2009, FOR THE TREATMENT OF PELVIC FLOOR PROLAPSE AND INCOMPLETE EMPTYING. ON (B)(6) 2021, THE PATIENT UNDERWENT A ROBOTIC SACRO COLPOPEXY WITH A TRANS OBTURATOR SLING AND POSTERIOR REPAIR DUE TO VAGINAL VAULT PROLAPSE, STRESS URINARY INCONTINENCE, AND RECTOCELE. ALTHOUGH THE PATIENT WAS 75 YEARS OLD, IT WAS NOTED THAT SHE LED A VERY ACTIVE, ROBUST LIFESTYLE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE PATIENT HAD SIGNIFICANT ADHESIONS WITH A SMALL AND LARGE BOWEL IN THE PELVIS THAT WERE VERY ADHERENT AND DENSE. ADDITIONALLY, THE PLANE BETWEEN THE RECTUM AND UNDERLYING VAGINA COULD NOT BE EASILY DEVELOPED DUE TO DENSE SCARRING AND ADHESIONS BETWEEN THE TWO STRUCTURES. WHEN THE VAGINAL MESH WAS IDENTIFIED, IT WAS NEARLY IMPOSSIBLE TO DISSECT. THE PHYSICIAN WAS ABLE TO DISS

  Patient problems: Erosion

  MAUDE report 17735844 ↗
• InjuryAug 8, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL DISSECTION AND ADHESIOLYSIS + PARTIAL SALPINGECTOMY ANTERIOR AND POSTERIOR COLPORRHAPHY + HIGH UTEROSACRAL VAGINAL VAULT SUSPENSION + TRANSOBUTRATOR MIDURETHRAL SLING PERFORMED ON (B)(6) 2014, FOR THE TREATMENT OF PELVIC PAIN, PERITONEAL TRACTION, OR MUSCULOSKELETAL PAIN, PELVIC ORGAN PROLAPSE WITH ANTERIOR AND POSTERIOR PROLAPSE AND APICAL PROLAPSE. FINDINGS SHOWED OVARIES ADHESED TO EACH OTHER AND ATTACHED TO THE VAGINAL CUFF UP UNDER THE BLADDER BASE AS WELL. IT WAS AN UNUSUAL PRESENTATION. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2022, THE PATIENT HAD REVISION SURGERY DUE TO URETHROVAGINAL FISTULA, EROSION OF MID URETHRAL SLING INTO THE URETHRA, CHRONIC PELVIC PAIN, RIGHT LOWER QUADRANT GREATER THAN LEFT LOWER QUADRANT PAIN, PERSISTENT RIGHT OVARIAN CYST, AND PELVIC FLOOR TENSION MYALGIA. THERE WAS THROUGH AND THROUGH EROSION OF THE SLING INTO THE URETHRA MAKING IT DIFFICULT TO PASS A FOLEY CATHETER. INTRAOPERATIVELY, THERE WAS A COMPLETE EROSION OF THE SLING AT 9:00 AND 3:00 WITH A COMPLETE PER

  Patient problems: Adhesion(s); Erosion; Fistula; Hematuria; Inflammation; Obstruction/Occlusion; Pain; Perforation; Scar Tissue

  MAUDE report 17478665 ↗
• InjuryAug 7, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A ROBOT - ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, TAP BLOCK, CYSTOSCOPY, AND TRANSOBUTRATOR SLING PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS INCONTINENCE, ABNORMAL UTERINE BLEEDING AND DYSMENORRHEA. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY IN GOOD CONDITION. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AS A RESULT OF THE IMPLANT: PAIN, INFLAMMATION, INFECTION, SEXUAL DYSFUNCTION, VAGINAL TISSUE INJURY, URINARY DYSFUNCTION, SURGERY FOR MESH REMOVAL AND EMOTIONAL AND MENTAL ANGUISH. ADDITIONALLY, THE PATIENT HAS SUFFERED THE FOLLOWING DAMAGES: PHYSICAL INJURY AND DEFORMITY; PHYSICAL DISABILITY, FUTURE MEDICAL CARE AND TREATMENT, MEDICAL EXPENSES, AND FUTURE OUT OF POCKET EXPENSES AND LOSS OF INCOME. ON (B)(6) 2022, THE PATIENT UNDERWENT PARTIAL REMOVAL OF THE MID-URETHRAL SLING AND CYSTOSCOPY DUE TO A DIAGNOSIS OF VAGINAL PAIN, DYSPAREUNIA, LEG, AND GROIN PAIN. FINDINGS SHOWED NO FOREIGN BODIES, INJURY, OR PATHOLOGY IN BLADDER OR URETHRA AS WELL AS BILATE

  Patient problems: Abdominal Pain; Calcium Deposits/Calcification; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Dyspnea; Dysuria; Fibrosis; Hematuria; Inflammation; Insufficient Information; Micturition Urgency; Pain; Sexual Dysfunction; Sleep Dysfunction; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 17467673 ↗
• InjuryJun 2, 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 SYSTEM-CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND TENSION-FREE VAGINAL TAPE USING A TRANSOBTURATOR APPROACH PROCEDURE ON (B)(6) 2005, FOR THE TREATMENT OF CHRONIC PELVIC PAIN, AN ENLARGED MULTI FIBROID UTERUS, AND STRESS URINARY INCONTINENCE. A LARGE MULTI FIBROID UTERUS ESSENTIALLY FILLING THE CUL-DE-SAC WAS FOUND DURING THE PROCEDURE. THE OVARIES WERE FREELY MOVABLE ON BOTH SIDES. BOTH OVARIES APPEARED NORMAL, WITH NO ABNORMAL PATHOLOGY DETECTED. THERE WAS NO FURTHER ABNORMAL PATHOLOGY IN THE PELVIS OR ABDOMEN. FURTHERMORE, THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT, WITH NO COMPLICATIONS. SHE WAS TAKEN TO THE RECOVERY ROOM AND APPEARED TO BE IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17056507 ↗
• InjuryMay 30, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A CYSTO WITH TRANSOBTURATOR TAPE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2008 TO TREAT STRESS URINARY INCONTINENCE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17020561 ↗
• InjuryMay 25, 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 SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING TRANSOBTURATOR TENSION-FREE VAGINAL TAPE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2007 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THROUGHOUT THE PROCEDURE, THERE WERE NO COMPLICATIONS NOTED. THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT, WHO WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17002801 ↗
• InjuryMay 15, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSOBTURATOR SLING PLACEMENT AND LAPAROSCOPIC BILATERAL TUBAL OCCLUSION PROCEDURE PERFORMED ON (B)(6) 2006 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AND PERMANENT STERILITY. THE PATIENT HAD ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL AS WELL AS THE SIGMOID EPIPLOICAE TO THE LEFT ANTERIOR ABDOMINAL WALL AND PELVIC SIDEWALL, WHICH WERE DISCOVERED DURING SURGERY. ADDITIONALLY, THE PATIENT HAD A HYPERMOBILE URETHRA. THE PATIENT ALSO TOLERATED THE PROCEDURE VERY WELL, AND SHE WAS MOVED TO THE RECOVERY AREA IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AS A RESULT OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16930498 ↗
• InjuryMay 1, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSOBTURATOR TAPE MID-URETHRAL SLING PLACEMENT, URETHROLYSIS SECONDARY TO SIGNIFICANT ADHESIONS IN THE PARA AND SUB-URETHRAL SPACES, AND CYSTOSCOPY PROCEDURES ON (B)(6) 2017, FOR THE TREATMENT OF URODYNAMIC STRESS INCONTINENCE. ACCORDING TO REPORTS, THE PATIENT HAD A HISTORY OF VAGINAL MESH KIT COMPLICATIONS FROM A VAGINAL MESH KIT THAT WAS IMPLANTED IN EARLY 2000 AND REMOVED A YEAR BEFORE THE OBTRYX SLING WAS INSERTED. FURTHERMORE, THE PATIENT TOLERATED THE PROCEDURE WELL, AND NO COMPLICATIONS WERE REPORTED THROUGHOUT THE PROCEDURE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16843315 ↗
• InjuryApr 24, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2006. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT CLAIMED TO HAVE SUFFERED PELVIC PAIN, DYSPAREUNIA, VAGINAL PAIN AND OTHER CHRONIC COMPLICATIONS OF MESH. SHE ALSO SUFFERED THE FOLLOWING DAMAGES SUCH AS PAST AND FUTURE MEDICAL AND INCIDENTAL EXPENSES, PAST AND FUTURE PHYSICAL IMPAIRMENT, PAST AND FUTURE DISFIGUREMENT, PAST AND FUTURE EMOTIONAL DISTRESS, PAST AND FUTURE PHYSICAL PAIN AND SUFFERING. IT WAS ALSO REPORTED THAT MEDICAL NEEDS OF THE PATIENT ARE ONGOING.

  Patient problems: Burning Sensation; Deformity/ Disfigurement; Dyspareunia; Dysuria; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Retention; Urinary Tract Infection

  MAUDE report 16797040 ↗
• InjuryApr 17, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN EXAM UNDER ANESTHESIA, ROBOTIC ASSISTED LAPAROSCOPIC COLPOPEXY, EXTENSIVE LYSIS OF ADHESIONS, AND LEFT OOPHORECTOMY PROCEDURES PERFORMED ON (B)(6) 2008, FOR THE TREATMENT OF SYMPTOMATIC PELVIC ORGAN PROLAPSE IN THE FORM OF A CYSTOCELE, RECTOCELE, AND VAULT PROLAPSE, A LEFT OVARIAN MASS, AND EXTENSIVE ADHESIONS. ALSO, THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT. THROUGHOUT THE PROCEDURE, THERE WERE NO COMPLICATIONS NOTED. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AS A RESULT OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16752542 ↗
• InjuryApr 16, 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 SYSTEM - CURVED DEVICE WAS IMPLANTED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH), TRANSOBTURATOR SLING IMPLANT FOR STRESS URINARY INCONTINENCE (SUI) AND CYSTOSCOPY PROCEDURES PERFORMED ON FEBRUARY 13, 2007 TO TREAT A PATIENT WITH UTEROVAGINAL PROLAPSE AND STRESS INCONTINENCE. FINDINGS INCLUDE: 1. EUA - NORMAL SIZE UTERUS, SECOND - THIRD DEGREE URETHROCELE. 2. INTRAOPERATIVE - SAME - DENSE BLADDER ADHESION. 3. INTRAOPERATIVE PHOTOS - YES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16748696 ↗