Obtryx™ System - Halo M0068505000Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 08714729718987), received between Apr 24, 2013 and Mar 2, 2026 — classified as 272 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MID-URETHRAL SLING PROCEDURE USING AN OBTRYX SYSTEM - HALO DEVICE, THE MESH WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484576 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX SYSTEM - HALO WAS IMPLANTED INTO A PATIENT ON (B)(6) 2025, AND SUBSEQUENTLY BECAME EXPOSED THROUGH THE VAGINA. REPORTED COMPLICATIONS INCLUDE VAGINAL DISCOMFORT, EROSION, AND EXTRUSION. IN THE PHYSICIAN'S OPINION, THE DEVICE CONTRIBUTED TO THESE COMPLICATIONS, WHICH ARE SUSPECTED TO BE DUE TO REJECTION OF THE SLING BY THE PATIENT'S BODY. THE EROSION WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP EVALUATION, WITH FINDINGS LOCALIZED TO THE VAGINA AND ASSOCIATED WITH THE SLING MATERIAL. NO PRIOR CATHETER PLACEMENT, RADIATION THERAPY, OR OTHER PROCEDURES WERE PERFORMED, AND NO INFECTION WAS IDENTIFIED. THE PATIENT REPORTED DISCOMFORT RATHER THAN SIGNIFICANT PAIN, DESCRIBING A SENSATION OF FEELING THE SLING VAGINALLY. TO DATE, THE DISCOMFORT HAS NOT BEEN TREATED, AND FURTHER MANAGEMENT IS UNDER CONSIDERATION.

  Patient problems: Discomfort; Erosion

  MAUDE report 24024243 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX SYSTEM - HALO ON (B)(6) 2024. APPROXIMATELY ONE YEAR LATER, DURING EVALUATION FOR ORGAN PROLAPSE, THE PHYSICIAN IDENTIFIED EXPOSURE AND EXTRUSION OF THE SLING WITHIN THE PATIENT'S VAGINA. THE PATIENT REPORTED ONGOING VAGINAL DISCOMFORT, WITH EROSION AND EXTRUSION INVOLVING THE PORTION OF THE SLING POSITIONED BENEATH THE URETHRA; THE EROSION WAS DIAGNOSED DURING REVISION ASSESSMENT. NO PRIOR CATHETER PLACEMENT, RADIATION THERAPY, OR OTHER PROCEDURES WERE PERFORMED, AND NO INFECTION WAS IDENTIFIED. TO DATE, NO MEDICAL OR SURGICAL INTERVENTIONS HAVE BEEN INITIATED, AND THE ISSUE REMAINS ONGOING. THE PHYSICIAN INDICATED THE DEVICE CAUSED OR CONTRIBUTED TO THE EROSION AND ATTRIBUTED BOTH THE EROSION AND THE PATIENT'S DISCOMFORT TO SUSPECTED REJECTION OF THE SLING BY THE PATIENT'S BODY. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2025; HOWEVER, NO FURTHER INFORMATION REGARDING PATIENT STATUS WAS RECEIVED. ADDITIONAL INFORMATION RECEIVED ON JANUARY 19, 2026: THE PATIENT PRESENTED WITH VAGINAL DISCOMFORT, URGE URINARY INCONTINENCE, AND DYSURIA. THE PHYSICIAN REPORTED THAT THE SLING WAS PALPABLE WITHIN THE ANTERIOR VAGINAL WALL

  Patient problems: Discomfort; Dysuria; Erosion; Inflammation; Perforation; Prolapse; Unspecified Infection; Unspecified Tissue Injury; Urinary Incontinence; Urinary Tract Infection; Weight Changes

  MAUDE report 24004911 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE PATIENT WAS IMPLANTED WITH A TRANSOBTURATOR TAPE (TOT) SLING ON PROCEDURE PERFORMED ON (b)(6) 2023, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE.ON (b)(6) 2023, THE PATIENT PRESENTED FOR EVALUATION FOLLOWING A RECENT EPISODE OF RIGHT LOWER EXTREMITY THROMBOSIS THAT OCCURRED IN THE SETTING OF UROLOGICAL SURGERY. AT THAT TIME, SHE DEVELOPED A RIGHT LOWER LIMB PAIN ASSOCIATED WITH FEVER, PROMPTING HOSPITALIZATION, DURING WHICH A THROMBOSIS OF THE RIGHT LOWER EXTREMITY WAS DIAGNOSED. SHE IS CURRENTLY RECEIVING THERAPEUTIC-DOSE ANTICOAGULATION. A COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY PERFORMED WAS NEGATIVE.SUBSEQUENTLY, A DOPPLER ULTRASOUND EXAMINATION DEMONSTRATED NORMAL PATENCY AND COMPRESSIBILITY OF THE DEEP VENOUS SYSTEM, INCLUDING THE INFERIOR VENA CAVA, WHICH WAS NOT DILATED, AS WELL AS THE COMMON ILIAC, FEMORAL, SUPERFICIAL FEMORAL, AND POPLITEAL VEINS. THESE VESSELS SHOWED COMPLETE COLOR FLOW WITH NO EVIDENCE OF RESIDUAL THROMBOSIS OR POST-THROMBOTIC SEQUELAE. THERE WAS NO EVIDENCE OF DEEP VENOUS REFLUX AT THE POPLITEAL LEVEL, AND NO SIGNS OF RECENT THROMBOSIS OR POST-THROMBOTIC CHANGES WERE OBSERVED AT THE SURAL LEVEL BILATERALLY

  Patient problems: Abnormal Vaginal Discharge; Chest Pain; Discomfort; Dyspnea; Ecchymosis; Erosion; Fatigue; Fever; Hematoma; Insufficient Information; Nerve Damage; Pain; Palpitations; Scar Tissue; Sleep Dysfunction; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Heart Problem; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Skin and Subcutaneous Tissue Problem; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 23996634 ↗
• InjuryNov 24, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, THE PHYSICIAN FOUND THAT THE ORIGINAL OBTRYX HALO SLING HAD BEEN POSITIONED TOO CLOSE TO THE BLADDER NECK, AND THE PATIENT CONTINUED TO EXPERIENCE URINARY INCONTINENCE. AN ADDITIONAL SURGERY USING NEW OBTRYX HALO SLING WAS DONE TO REMOVE ABOUT SIX CENTIMETERS OF THE ORIGINAL SLING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 23637397 ↗
• InjuryNov 20, 2025Malposition of Device; Malposition of Device

  F2IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE PELVIC FLOOR REPAIR KIT WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2010, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. IT WAS NOTED THAT DURING THE SAME PROCEDURE, AN OBTRYX SLING WAS PLACED, AND A PARTIAL HYSTERECTOMY WAS ALSO PERFORMED. IT WAS NOTED THAT LEADING TO THE PROCEDURE, THE PATIENT HAD BEEN DIAGNOSED WITH PELVIC PAIN, THIRD-DEGREE CYSTOCELE, RECTOCELE, UTERINE PROLAPSE, STRESS URINARY INCONTINENCE, AND ENDOMETRIOSIS. INTRA-ABDOMINAL ADHESIONS WERE NOTED AND LYSED DURING THE SURGERY. IN OR AROUND 2014, THE PATIENT STARTED HAVING SEVERE PELVIC PAIN. THE PATIENT WAS THOUGHT TO BE INCORRECTLY DIAGNOSED WITH ENDOMETRIOSIS CAUSING THE SEVERE PAIN TO BECOME CHRONIC. IN OR AROUND 2016, THE PATIENT UNDERWENT AN OOPHORECTOMY ATTEMPTING TO RESOLVE HER SYMPTOMS; HOWEVER, NO IMPROVEMENT WAS NOTED; THIS CAUSED HER SEVERE DEPRESSION AND ANXIETY. THE PATIENT ALLEGED THAT THE CHRONIC PAIN WAS DISMISSED. ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH DYSPAREUNIA, PELVIC PAIN, AND VAGINAL BLEEDING. SHE UNDERWENT LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY AND BILATERAL ANTERIOR VAGINAL WALL MESH A

  Patient problems: Abscess; Anxiety; Depression; Dyspareunia; Dysuria; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 23605896 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL HISTORY: THE PATIENT'S MEDICAL HISTORY INCLUDES A FORCEPS DELIVERY PROCEDURE IN 2009, TYPE 1 BIPOLAR DISORDER (STABLE UNDER PSYCHIATRIC CARE), AND LITHIUM-INDUCED DIABETES INSIPIDUS. IT WAS REPORTED THAT A TRANSOBTURATOR (TOT) SLING WAS IMPLANTED TO THE PATIENT ON (B)(6) 2017, FOR THE TREATMENT OF WORSENING STRESS URINARY INCONTINENCE AND CERVICOURETERAL HYPERMOBILITY. ON (B)(6) 2020, THE PATIENT EXPERIENCED MULTIPLE URINARY TRACT INFECTIONS (UTIS) AND EPISODES OF PYELONEPHRITIS. SHE DEVELOPED CHRONIC PELVIC AND PERINEAL PAIN INVOLVING THE LOWER ABDOMEN, VAGINA, BLADDER, ADDUCTORS, AND BOTH LEGS AND FEET, INCLUDING THE OBTURATOR AREAS. PAIN MANAGEMENT INCLUDED ACUPAN, MORPHINE, AND TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) THERAPY. IN (B)(6) 2024, THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS, NOTING APPROXIMATELY ONCE PER MONTH. THESE UTIS WERE MANAGED WITH SHORT COURSES OF ANTIBIOTICS. ON THE SIX MONTHS PRIOR TO THIS APPOINTMENT, THE PATIENT HAD DEVELOPED PROGRESSIVE VAGINAL AND PELVIC PAIN, MOST PRONOUNCED IN THE RIGHT AND LEFT GROIN FOLDS, DESCRIBED AS PULSATILE, THROBBING, AND PEAK-TYPE PAIN, OCCASIONALLY ASSOCIATED WITH AN INTRAVAGINAL FOREIGN BO

  Patient problems: Abdominal Pain; Anxiety; Depression; Erosion; Nerve Damage; Pain; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Urinary Tract Infection

  MAUDE report 23405657 ↗
• InjurySep 10, 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 RECURRENT MESH EROSIONS INTO THE URETHRA WITH CALCIFICATION, PELVIC AND FLANK PAIN, WORSENING URINARY ISSUES, RECURRENT URINARY TRACT AND BLADDER INFECTIONS, AND A 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: Calcium Deposits/Calcification; Erosion; Pain; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Tract Infection

  MAUDE report 23018250 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE OBTRYX SYSTEM - HALO IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS. THESE INCLUDE MESH EROSION AND EXPOSURE, VAGINAL BLEEDING, DISCOMFORT, DIFFICULTY URINATING, AND DYSPAREUNIA. SUBSEQUENTLY, THE PATIENT UNDERWENT MESH REVISION SURGERY ON (B)(6) 2024. SHE ALSO CLAIMED TO HAVE SUFFERED SEVERE PAIN, UNNECESSARY EXPENSES, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTATION. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY NEED TO UNDERGO FURTHER SURGERY AND MAY, IN THE FUTURE, SUFFER DAMAGES SUCH AS SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

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

  MAUDE report 22852264 ↗
• InjuryMay 30, 2025Adverse 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 DURING THE SAME PROCEDURE. PLEASE REFER TO MANUFACTURER REPORT 2124215-2025-31156 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX SYSTEM - HALO IMPLANTED DURING A PROCEDURE ON (B)(6) 2019, AND A SOLYX SIS SYSTEM IMPLANTED ON (B)(6) 2021. DURING THE (B)(6) 2019 PROCEDURE, THE OBTRYX SYSTEM - HALO SLING WAS PLACED VIA A TRANSOBTURATOR APPROACH USING HALO NEEDLES. THE SLING WAS POSITIONED AND TENSIONED UNDER DIRECT CYSTOSCOPIC VISUALIZATION, WHICH CONFIRMED A NORMAL BLADDER AND NO UNDUE TENSION AT THE MID-URETHRA. EXCESS SLING MATERIAL WAS EXCISED, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. ON (B)(6) 2021, THE PATIENT UNDERWENT MULTIPLE PELVIC RECONSTRUCTIVE PROCEDURES TO ADDRESS SYMPTOMATIC PELVIC FLOOR RELAXATION, PELVIC PAIN, DYSPAREUNIA, AND MIXED URINARY INCONTINENCE, WITH STRESS URINARY INCONTINENCE CONFIRMED BY URODYNAMIC STUDIES. AMONG THE PROCEDURES PERFORMED WAS PLACEMENT OF A SECOND TRANSOBTURATOR TAPE MID-URETHRAL SLING. THE PRIOR SLING WAS REMOVED, AND A NEW SLING WAS INSERTED USING THE OBTRYX HALO NEEDLE TECHNIQUE THROUGH THE LABIAL CRURAL FOLDS TO THE OBTURATOR ME

  Patient problems: Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Erosion; Inflammation; Insufficient Information; Pain; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 22116723 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 2124215-2025-25099 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX SYSTEM AND UPHOLD VAGINAL SUPPORT SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING EXTENSIVE VAGINAL MESH EROSION, MESH EXTRUSION, RECURRENT PROLAPSE, VAGINAL DISCHARGE, ABNORMAL BLEEDING, PAIN INCLUDING VAGINAL PAIN, DYSPAREUNIA, FURTHER OR WORSENING URINARY PROBLEM, 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; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Prolapse; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Retention

  MAUDE report 21888171 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOMETIME AFTER IMPLANTATION, THE PATIENT HAD SUFFERED URETHRAL STRICTURE, EROSION OF SUBURETHRAL SLING, PELVIC PAIN, EPIDERMAL CYST OF VULVA, FURTHER OR WORSENING URINARY PROBLEMS, AND LOSS OF ENJOYMENT OF LIFE. FURTHERMORE, THE PATIENT CLAIMS TO HAVE SUFFERED, OR MAY SUSTAIN IN THE FUTURE, THE FOLLOWING DAMAGES AS A RESULT OF THE IMPLANTATION OF THE OBTRYX? SYSTEM - HALO DEVICE: PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL CARE EXPENSES.

  Patient problems: Abdominal Pain; Discomfort; Dysuria; Erosion; Insufficient Information; Localized Skin Lesion; Micturition Urgency; Pain; Unspecified Kidney or Urinary Problem; Urethral Stenosis/Stricture; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 21861816 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THE OBTRYX HALO DEVICE EXPERIENCED AN UNSPECIFIED INJURY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION OF THE MID-URETHRAL SLING AND CYSTOSCOPY PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 21618231 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH AN OBTRYX HALO DEVICE EXPERIENCED AN UNSPECIFIED INJURY LEADING TO THE MESH BEING EXPLANTED. THE PATIENT ALSO UNDERWENT A ROBOTIC SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, SACROCOLPOPEXY, ENTEROCELE REPAIR, POSTERIOR REPAIR, MID-URETHRAL SLING PLACEMENT, AND CYSTOSCOPY PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 21618229 ↗
• InjuryMar 5, 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 EXPERIENCED EROSION. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Erosion

  MAUDE report 21527965 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX SYSTEM - HALO DEVICE WAS USED DURING A PROCEDURE. THE PATIENT EXPERIENCED PELVIC HEAVINESS AND NEEDS TO URINATE FREQUENTLY. OTHER PAINS HAVE ALSO APPEARED PROGRESSIVELY, SUCH AS BACK, PELVIC, HIP, STERNUM, SHOULDER, AND FOOT PAIN. ADDITIONALLY, THE PATIENT ALSO HAD ANAL AND VAGINAL BURNING.

  Patient problems: Burning Sensation; Pain; Prolapse; Urinary Frequency / Polyuria

  MAUDE report 20698868 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE OBTRYX SLING FIXED ON THE RIGHT SIDE OF HER VAGINA. THE PATIENT HAS EXPERIENCED PAIN IN THE RIGHT GROIN, STOMACH, VAGINA, RECTUM, LEG, AND RIGHT FOOT. THE PATIENT INDICATED BEING UNABLE TO WALK FOR TOO LONG OR DRIVE LONG DISTANCES. THE PATIENT ALLEGED THE CONSTANT PAIN PREVENTED HER FROM JOINING A NEW JOB, AND FROM HAVING A NORMAL LIFE. IT WAS STATED THAT THE SHORT, PAINFUL NIGHTS, THE ISOLATION FROM HER CHILDREN AND FAMILY, AND INABILITY TO MAINTAIN SEXUAL INTERCOURSE HAS LED TO DEPRESSION. NO ACTIONS WERE REPORTED TO BE TAKEN IN A HEALTHCARE FACILITY TO ADDRESS THE SYMPTOMS.

  Patient problems: Depression; Dyspareunia; Pain

  MAUDE report 20481178 ↗
• 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 AN OBTRYX SYSTEM-HALO DEVICE IMPLANT PROCEDURE ON (B)(6) 2019. DURING THE SAME SURGERY, TOTAL VAGINAL HYSTERECTOMY, A SALPINGECTOMY, ANTERIOR AND POSTERIOR REPAIR, ENTEROCELE REPAIR, PERINEOPLASTY, AND VAGINAL SUSPENSION PROCEDURES WERE ALSO PERFORMED. IT WAS NOTED THAT FOLLOWING THIS PROCEDURE, THE PATIENT DEVELOPED VAGINAL CUFF CELLULITIS. ON AUGUST 26, 2022, THE PATIENT WAS DIAGNOSED WITH CHRONIC PELVIC PAIN AND URINARY DYSFUNCTION. THE PATIENT UNDERWENT AN EXAM UNDER ANESTHESIA, REVEALING SEVERE VAGINAL SCARRING OF THE ANTERIOR VAGINAL WALL AND VAGINAL CUFF. CYSTOSCOPY CONFIRMED THE BLADDER WAS ENLARGED WITH LEFT AND RIGHT POSTERIOR WALL DIVERTICULAE; HOWEVER, NO FOREIGN BODIES, LESIONS OR TRAUMA WERE NOTED. SUBSEQUENTLY, A PARTIAL SLING REMOVAL WAS PERFORMED. AFTER CAREFUL DISSECTION THROUGH DENSE SCAR TISSUE, THE TRANSOBTURATOR SLING WAS FOUND AT THE LEVEL OF THE BLADDER NECK. THE DISSECTION WAS TAKEN BACK TO THE LEVEL OF THE BILATERAL INFERIOR PUBIC RAMI TO RELEASE THE MAXIMUM AMOUNT OF SLING MESH. EVALUATION OF THE URETHRA DEMONSTRATED TIT TO BE INTACT. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT UNDERWENT A SERIES OF 3 ML ALIQUOTS

  Patient problems: Dyspareunia; Insufficient Information; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 19762973 ↗
• MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN OBTRYX SYSTEM - HALO DEVICE WAS USED DURING A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TUNNELING NEEDLE LACKED SOLIDARIZATION BETWEEN THE PLASTIC SHEATH OF THE MESH WITH THE BLUE END THAT WAS EQUIPPED WITH A METALLIC RING FOR POSITIONING AND FOR SLING TRACTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237543 ↗
• InjuryApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MID-URETHRAL SLING PROCEDURE USING AN OBTRYX SYSTEM - HALO, WHEN THE TROCAR WAS RETRACTED THROUGH THE PATIENT, THE TIP OF THE SLING SYSTEM, CONSISTING OF THE ASSOCIATION LOOP AND BLUE DILATOR, DETACHED FROM THE PLASTIC SLEEVE CONTAINING THE MESH. THE PHYSICIAN THEN PULLED OUT THE PORTION OF THE PLASTIC SLEEVE THAT HAD BEEN INTRODUCED INTO THE PATIENT. IN ADDITION, A SMALL PLASTIC COMPONENT THAT CONNECTED THE DILATOR AND SLEEVE WAS FOUND DETACHED INSIDE THE PATIENT AND WAS RETRIEVED FROM HER TISSUE USING A TOOL. UPON EXAMINATION OF THE DEVICE OUTSIDE THE PATIENT, IT APPEARED THAT THE BLUE DILATOR AND PLASTIC SHEATHS HAD NOT BEEN PROPERLY SEALED TOGETHER DURING PRODUCTION. THE OTHER SIDE OF THE SLING SYSTEM WAS THEN EXAMINED, AND IT APPEARED THAT SIDE HAD THE SAME PROBLEM. A PHOTO OF THE DEVICE OUTSIDE THE PATIENT WAS PROVIDED, SHOWING BOTH THE DELIVERY DEVICES AND THE PROTECTIVE SLEEVES. ONE OF THE BLUE DILATORS WAS STILL ATTACHED TO THE INTRODUCER AND WAS DETACHED FROM THE CLEAR PLASTIC SLEEVE. ANOTHER MESH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, WITH EXTENDED OPERATING TIME REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175263 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OBTRYX SYSTEM DEVICE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DUE TO THE IMPLANTATION, THE PATIENT EXPERIENCED INJURIES INCLUDING INCOMPLETE EMPTYING OF BLADDER, FREQUENT URINATION, URINARY TRACT INFECTIONS, URGE INCONTINENCE, EROSION OF MESH, MESH TRANSECTING THE URETHRA, AND REQUIRED ADDITIONAL MEDICAL TREATMENT AND PROCEDURES INCLUDING REPAIR AND REMOVAL.

  Patient problems: Erosion; Micturition Urgency; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 19121450 ↗
• InjuryMar 5, 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 - HALO WAS IMPLANTED INTO THE PATIENT DURING A TRANSOBTURATOR TAPE (TOT) PROCEDURE PERFORMED ON (B)(6) 2021. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF RIGHT THIGH PAIN, GROIN PAIN, SCIATIC LEG PAIN, HIP PAIN, BUTTOCK PAIN, AND LOWER BACK PAIN. SHE HAS DIFFICULTY SITTING OR STANDING FOR TOO LONG, WALKING, GETTING IN AND OUT OF THE CAR, AND CLIMBING THE STAIRS. SHE HAS A TINGLING SENSATION IN HER LEG AND A BURNING SENSATION IN THE BUTTOCK, THIGH, AND LOWER BACK. SHE LIMPS WHENEVER SHE GETS OUT OF THE CAR. SHE HAS A BLOCKED HIP AND PELVIS SENSATION. SHE HAS PAIN AND DISCOMFORT IN HER LOWER RIGHT BELLY AND HAS RIGHT GROIN SENSITIVITY. THE PATIENT CAN NO LONGER FEEL HER STRAIGHT LEG AND FOOT DUE TO FEELING NUMB. SHE HAS DIFFICULTY SLEEPING BECAUSE THE POSITION ON ONE SIDE IS COMPLICATED; THERE IS STAB-LIKE PAIN IN HER HIP AND BUTTOCKS. SHE HAS FATIGUE AND FREQUENT CONSTIPATION.

  Patient problems: Abdominal Pain; Burning Sensation; Constipation; Discomfort; Fatigue; Movement Disorder; Numbness; Pain; Paresthesia; Sleep Dysfunction

  MAUDE report 18838886 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES IMPLANTED IN SEPARATE PROCEDURES. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OBTRYX SYSTEM - HALO WAS IMPLANTED INTO THE PATIENT DURING A TRANSOBTURATOR TAPE (TOT) PROCEDURE PERFORMED ON (B)(6) 2021. FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED FOR PAIN SEVERAL TIMES. THE PATIENT NOTED SHE NEVER HAD THIS KIND OF PAIN BEFORE THE IMPLANTATION OF THE PROSTHESIS. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. ON (B)(6) 2023, A PELVIC ULTRASOUND WAS PERFORMED AND SHOWED NO ABNORMALITY OF THE URETHRAL BLADDER CHANNEL. THE ENTIRE BLADDER MUCOSA WAS NORMAL, NO TRIGONITIS, EROSION, STONES, ABNORMAL AREAS, AND UROTHELIAL LESIONS. THERE WAS A SMALL SWELLING UNDER THE URETHRAL MUCOSA INSIDE THE RIGHT URETERAL MEATUS. THE CYSTOSCOPY WAS NORMAL APART FROM THE PAIN ON PALPATION OF THE VAGINAL CUL-DE-SAC. THE PATIENT IS CURRENTLY HAVING CONSTANT PELVIC PAIN, DIFFICULTY WALKING (MUST LIE DOWN AS MUCH AS POSSIBLE TO BE ABLE TO WALK FOR TWO HOURS), PAIN IN BOTH GROINS, IN THE PELVIS, IN THE LEGS, DYSPAREUNIA, LABOR-LIKE PAIN, AND NEEDLE-LIKE PAIN. SHE HAS RECURRENT URINARY INFECTIONS, PROBLEMS EMPTYING THE BLADDER, FREQUENT U

  Patient problems: Dyspareunia; Dysuria; Micturition Urgency; Movement Disorder; Pain; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 18784705 ↗
• InjuryFeb 6, 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 - HALO WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023, ON A PATIENT WITH A MEDICAL HISTORY THAT INCLUDES ENDOMETRIOSIS, AND THROMBOSIS OF THE OVARIAN VEIN. ADDITIONALLY, THE PATIENT HAD UNDERGONE PREVIOUS UNRELATED SURGERIES INCLUDING THREE CESAREAN SECTIONS, TUBAL LIGATION, AND RIGHT OVARIAN CYST LAPAROSCOPY. IT WAS REPORTED THAT AFTER PLACING THE MESH, THE PATIENT EXPERIENCED A PAINFUL AWAKENING WITH RIGHT THIGH PAIN, PERINEAL PAIN, AND DIFFUSED PAIN ON EACH SIDE, A FOLD ON THE RIGHT GROIN, THIGH STABBING SENSATION, DIFFICULTY TO SIT AND STAND FOR LONG PERIODS, AND DIFFICULTY IN URINATING. ON (B)(6) 2023, A SURGICAL REVISION WAS PERFORMED IN WHICH THE RIGHT BRANCH OF THE SLING AND THE LEFT PARTIAL BRANCH OF THE MESH WERE REMOVED. DURING THE HOSPITAL STAY FOR THE PROCEDURE, THE PATIENT RECEIVED ADDITIONAL TESTS WHICH INCLUDED A BLOOD TEST AND COMPUTED TOMOGRAPHY (CT) SCANS OF THE ABDOMEN AND PELVIS; BOTH OF WHICH HAD NORMAL RESULTS. NO SIGNS OF HEMATOMA, INFECTION OR INFLAMMATORY SYNDROME WERE IDENTIFIED. ADDITIONALLY, THE PATIENT HAD A DOPPLER ECHOGRAPHY OF THE RIGHT INGUINAL FOLD WHICH FOUND A SMAL

  Patient problems: Depression; Dysuria; Pain; Thrombosis/Thrombus; Urinary Retention

  MAUDE report 18654640 ↗
• InjuryOct 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 - HALO DEVICE WAS IMPLANTED INTO THE PATIENT DURING A ROBOTIC-ASSISTED LAPAROSCOPIC SACROCOLPOPEXY, CYSTOSCOPY, OBTRYX TRANSOBTURATOR URETHRAL SLING, AND POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2021. AS A RESULT OF THE IMPLANTATION OF THE PELVIC MESH, THE PATIENT SUFFERED THE INJURIES SUCH AS RECTAL AND VAGINAL PROLAPSE, BACK PAIN, ABDOMINAL PAIN, URETHRAL ATROPHY, CHRONIC PELVIC PAIN, CHRONIC CONSTIPATION, AND DYSURIA. ADDITIONALLY, THE PATIENT UNDERWENT ADDITIONAL MEDICAL TREATMENT AND PROCEDURES, INCLUDING REPAIR AND PELVIC MESH REMOVAL.

  Patient problems: Abdominal Pain; Constipation; Dysuria; Pain; Prolapse; Unspecified Tissue Injury

  MAUDE report 18008624 ↗