Advantage Fit™ Blue System M0068502120Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 08714729961925), received between Oct 5, 2018 and Apr 6, 2026 — classified as 69 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ADVANTAGE FIT BLUE SYSTEM DEVICE WAS USED DURING A TRANSVAGINAL MID-URETHRAL SLING PROCEDURE. DURING PLACEMENT, THE SLING BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795788 ↗
• MalfunctionMar 25, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE INITIAL INSERTION OF THE ADVANTAGE FIT BLUE DEVICE, THE SLING SNAPPED. ALL PIECES WERE REPORTEDLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITH A NEW SLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694004 ↗
• InjuryMar 4, 2026Nonstandard Device

  IT WAS REPORTED THAT AN ADVANTAGE FIT BLUE SYSTEM WAS IMPLANTED ON (B)(6) 2020, TO TREAT A PATIENT WITH STRESS URINARY INCONTINENCE, WHICH BECAME APPARENT FOLLOWING HER PROLAPSE REPAIR. FOLLOWING THE IMPLANTATION, THE PATIENT EXPERIENCED MESH RELATED COMPLICATIONS, INCLUDING PERSISTENT PELVIC AND PERINEAL PAIN, BLADDER NECK EROSION, AND INTRAVESICAL CALCIFICATIONS. IN 2024, THE PATIENT WAS PARTIALLY TREATED ENDOSCOPICALLY FOR THE CALCIFICATIONS; HOWEVER, FOLLOW UP IMAGING CONFIRMED RESIDUAL CALCIFICATIONS. THE PATIENT CONTINUED TO REPORT SIGNIFICANT VULVAR PAIN ALONG THE SLING PATH AND AT THE SITES OF INTRAVESICAL CALCIFICATIONS. DUE TO PERSISTENT SYMPTOMS AND ASSOCIATED LESIONS, A COMPLETE REMOVAL OF THE MESH VIA ROBOT-ASSISTED LAPAROSCOPY WAS SCHEDULED ON (B)(6) 2026.

  Patient problems: Calcium Deposits/Calcification; Erosion; Pain; Urinary Incontinence

  MAUDE report 24507286 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BOSTON SCIENTIFIC MESH WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. FOLLOWING THE IMPLANTATION, THE PATIENT HAS EXPERIENCED EROSION; HOWEVER, NO MEDICAL INTERVENTIONS HAVE BEEN PERFORMED TO ADDRESS THE SYMPTOM. ADDITIONALLY, THE PHYSICIAN BELIEVES THAT SINCE THE SLING INTRODUCER FEATURES A ROUNDED METAL TIP THAT REQUIRES SIGNIFICANT FORCE TO TRAVERSE THE CONNECTIVE TISSUE LAYERS OF THE ANTERIOR PELVIS AND ANTERIOR ABDOMINAL WALL, IT COULD POTENTIALLY INCREASE THE RISK OF PERFORATION.

  Patient problems: Erosion

  MAUDE report 24470296 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT BLUE SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE SAME SURGERY, ANTERIOR COLPORRHAPHY, SUBURETHRAL SLING, CYSTOSCOPY, POSTERIOR COLPORRHAPHY, AND ENTEROCELE REPAIR VAGINAL APPROACH PROCEDURES WERE ALSO PERFORMED. ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH MIXED STRESS AND URGE URINARY INCONTINENCE. SHE UNDERWENT PARTIAL EXCISION OF MESH. DURING THE SAME PROCEDURE, CYSTOURETHROSCOPY AND ANTERIOR COLPORRHAPHY PROCEDURES WERE ALSO PERFORMED. DURING THE PROCEDURE, PALPATION OF THE URETHRA REVEALED NO EVIDENCE OF MESH EXTRUSION. THE CYSTOSCOPE SHEATH WAS ADVANCED INTO THE BLADDER AND THEN WITHDRAWN SLOWLY WITH THE SCOPE TIP DIRECTED DOWNWARD UNTIL A SUBTLE "STEP-OFF" WAS USED TO IDENTIFY THE MESH. A MIDLINE INCISION WAS MADE AT THE LEVEL OF THE MID-URETHRA AND BLADDER NECK, AND THE VAGINAL EPITHELIUM WAS CAREFULLY DISSECTED OFF THE PERIURETHRAL FASCIA TO CREATE TISSUE FLAPS FOR CLOSURE FOLLOWING MESH EXCISION. THE MESH WAS IDENTIFIED AND ISOLATED FROM THE URETHRA USING RIGHT-ANGLE CLAMPS, THEN FURTHER EXPOSED THROUGH A COMBINATION OF

  Patient problems: Urinary Incontinence

  MAUDE report 24336853 ↗
• MalfunctionJan 9, 2026Positioning Failure; Difficult to Advance

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT BLUE SYSTEM, THE PHYSICIAN INITIALLY ATTEMPTED TO PLACE THE SLING ON THE PATIENT'S LEFT SIDE BUT ENCOUNTERED RESISTANCE WHILE ADVANCING THE TROCAR INTO THE RETROPUBIC SPACE. AFTER SEVERAL ATTEMPTS, THE DEVICE WAS SUCCESSFULLY PASSED, AND INTRAOPERATIVE CYSTOSCOPY CONFIRMED NO BLADDER INJURY. THE PHYSICIAN THEN ATTEMPTED PLACEMENT ON THE RIGHT SIDE AND EXPERIENCED SIMILAR DIFFICULTY ADVANCING THE DEVICE AS INTENDED. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN ELECTED TO OPEN AND USE A NON-BOSTON SCIENTIFIC DEVICE TO COMPLETE THE RIGHT-SIDED PLACEMENT. THE ADVANTAGE FIT DEVICE WAS SUBSEQUENTLY REMOVED FROM THE LEFT SIDE AND REPLACED WITH THE NON-BOSTON SCIENTIFIC DEVICE. A REPEAT CYSTOSCOPY CONFIRMED NO BLADDER INJURY. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029787 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE FIT BLUE WAS IMPLANTED TO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2025. APPROXIMATELY TWO WEEKS FOLLOWING THE IMPLANTATION, THE PATIENT HAS EXPERIENCED PERSISTENT ITCHING WHICH HAS IMPROVED OVER TIME BUT STILL PERSISTS. ASIDE FROM CHRONIC ITCHING, NO ADDITIONAL SYMPTOMS WERE REPORTED, AND THE PATIENT'S CURRENT CONDITION IS OTHERWISE NORMAL. WHILE ATTEMPTING TO IDENTIFY THE CAUSE, THE PATIENT DISCLOSED AN ALLERGY TO COBALT BLUE, PROMPTING THE PHYSICIAN TO INQUIRE ABOUT THE DYE USED IN THE MESH. THE PHYSICIAN NOTED THAT THE PATIENT MAY ALSO HAVE AN ALLERGY TO COPPER AND FURTHER EVALUATION WAS DIRECTED. THE PATIENT HAS BEEN SCHEDULED TO UNDERGO ALLERGY SKIN TESTING IN (B)(6) 2025. IN THE PHYSICIAN'S OPINION, IT IS CURRENTLY UNCERTAIN WHETHER THE DEVICE OR PROCEDURE CONTRIBUTED TO THE PATIENT'S SYMPTOMS, PENDING THE RESULTS OF ALLERGY TESTING. TO DATE, MANAGEMENT HAS INCLUDED MEDICAL TREATMENT FOR CHRONIC ITCHING AND TREATMENT FOR SCABIES, WITH ALLERGY PATCH TESTING IDENTIFIED AS THE NEXT STEP IN EVALUATION.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 23787019 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PLACEMENT OF THE ADVANTAGE FIT MID-URETHRAL SLING DURING A PELVIC SURGERY FOR STRESS URINARY INCONTINENCE, ALONGSIDE OPERATIVE LAPAROSCOPY FOR PELVIC PAIN, HYSTEROSCOPY, AND DIAGNOSTIC CYSTOSCOPY. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATION. NO BLEEDING OR INTRAOPERATIVE CONCERNS WERE NOTED, AND THE PATIENT TOLERATED THE PROCEDURE WELL. FOLLOWING THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING CHRONIC PELVIC PAIN. ON (B)(6) 2024, SHE UNDERWENT A CYSTOSCOPY WITH LASER EXCISION OF BLADDER MESH. DURING THE PROCEDURE, A SEGMENT OF THE SLING WAS OBSERVED TRAVERSING THE RIGHT LATERAL BLADDER WALL, WITH A STONE ADHERENT TO THE MESH. A 350-WATT LASER WAS USED TO EXCISE THE MESH STARTING AT ITS DISTAL EDGE. THE PROXIMAL ENDS WERE ALSO LASERED BACK BEHIND THE BLADDER WALL, AVOIDING DEEPER DISSECTION TO PREVENT CYSTOTOMY. THE STONE AND MESH MATERIAL WERE REMOVED. FOLLOWING THIS, THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS. ON (B)(6) 2024, SHE UNDERWENT A SECOND CYSTOSCOPIC PROCEDURE FOR LASER ABLATION OF RESIDUAL MESH. A SMALL AMOUNT OF ERODED MESH WAS AGAIN IDENTIFIED AT THE RIGHT LATERAL BLADDER SIDEWALL, WITH SOME SEDIMENT PRESENT. THE

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Pain

  MAUDE report 22566790 ↗
• InjuryJun 30, 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 AN ADVANTAGE FIT SYSTEM AND HAS SINCE EXPERIENCED NUMEROUS INJURIES, INCLUDING, BUT NOT LIMITED TO CHRONIC PELVIC PAIN, RECURRENT URINARY TRACT INFECTIONS, VOIDING DYSFUNCTION, PELVIC FLOOR DYSFUNCTION, VAGINAL AND URETHRAL ATROPHY, AND PAIN DURING INTERCOURSE. SUBSEQUENTLY, SHE UNDERWENT A REVISION SURGERY ON (B)(6) 2023, AND A PARTIAL EXCISION ON (B)(6) 2023. DESPITE THIS, THE PATIENT HAS SUFFERED SIGNIFICANT PAIN, DISFIGUREMENT, EMBARRASSMENT, AND UNNECESSARY EXPENSE. SHE MAY REQUIRE ADDITIONAL SURGERY AND LONG-TERM MEDICAL TREATMENT. THE PATIENT HAS SUSTAINED AND IS EXPECTED TO CONTINUE SUSTAINING SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, AND MENTAL AND PHYSICAL PAIN AND SUFFERING, ALONG WITH ONGOING ECONOMIC LOSSES THAT MAY PERSIST FAR INTO THE FUTURE.

  Patient problems: Deformity/ Disfigurement; Dyspareunia; Pain; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 22366476 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF AN ADVANTAGE FIT SYSTEM AND HAS SINCE EXPERIENCED MULTIPLE INJURIES, INCLUDING CONSTIPATION, BLADDER OUTLET OBSTRUCTION NECESSITATING SELF-CATHETERIZATION, URINARY TRACT INFECTION, URINARY URGENCY AND FREQUENCY, URGE INCONTINENCE, AND DYSURIA. SUBSEQUENTLY, SHE UNDERWENT MESH REMOVAL ON (B)(6) 2023. DESPITE THIS, THE PATIENT HAS SUFFERED SIGNIFICANT PAIN, DISFIGUREMENT, EMBARRASSMENT, AND FINANCIAL LOSS DUE TO UNNECESSARY EXPENSES AND LOST WAGES. SHE MAY REQUIRE ADDITIONAL SURGERY AND ONGOING TREATMENT. THE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, AND MENTAL AND PHYSICAL PAIN AND SUFFERING, WITH ECONOMIC LOSSES EXPECTED TO CONTINUE FAR INTO THE FUTURE.

  Patient problems: Constipation; Deformity/ Disfigurement; Dysuria; Micturition Urgency; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 22366466 ↗
• InjuryMay 29, 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 AN ADVANTAGE FIT BLUE SYSTEM ON (B)(6) 2023. AS A RESULT OF THE MESH IMPLANT, THE PATIENT EXPERIENCED RECURRING INFECTIONS, ABDOMEN, GROIN, TAIL-BONE REGION, HIP, AND MYOFASCIAL PAIN, INCREASED MUSCLE TENSION AND TRIGGER POINTS WITHIN THE RIGHT OBTURATOR INTERNUS, PUBOCOCCYGEUS, AND BLADDER BASE, AND DYSPAREUNIA. ON (B)(6) 2023, THE PATIENT COMPLAINED OF RIGHT-SIDED ABDOMINAL AND FLANK PAIN THAT HAD WORSENED SINCE UNDERGOING MESH IMPLANT SURGERY APPROXIMATELY THREE WEEKS EARLIER. SHE REPORTED PERSISTENT RIGHT LOWER ABDOMINAL PAIN, ALTHOUGH PRIOR IMAGING HAD REPORTEDLY BEEN NEGATIVE FOR APPENDICITIS. THE PATIENT STATED SHE WAS CURRENTLY TAKING CIPROFLOXACIN FOR A URINARY TRACT INFECTION AND NOTED THAT SHE HAD RECENTLY PASSED MATERIAL IN HER URINE, THOUGH SHE WAS UNSURE WHETHER IT REPRESENTED A KIDNEY STONE. SHE DESCRIBED ONGOING RIGHT-SIDED FLANK PAIN SINCE THE SLING PROCEDURE, ACCOMPANIED BY BURNING WITH URINATION. THE PATIENT REPORTED MULTIPLE PRIOR EMERGENCY DEPARTMENT VISITS FOR SIMILAR SYMPTOMS. A PREVIOUSLY PERFORMED COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN HAD BEEN REPORTED AS NORMAL, AND SHE HAD BEEN DISCHARGED AT THAT

  Patient problems: Abdominal Pain; Burning Sensation; Cramp(s) /Muscle Spasm(s); Dyspareunia; Dysuria; High Blood Pressure/ Hypertension; Nausea; Pain; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 22110686 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE ON (B)(6) 2021. CYSTOURETHROSCOPY SHOWED NO BLADDER PERFORATION OR INTRAVESICAL ABNORMALITIES, AND THE SLING WAS NOT VISIBLE INSIDE THE BLADDER. SHE TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY UNIT IN STABLE CONDITION. NO COMPLICATIONS WERE REPORTED. SHE WAS ADMITTED OVERNIGHT FOR OBSERVATION, WITH PLANS TO REMOVE THE FOLEY CATHETER AND VAGINAL PACKING THE FOLLOWING DAY BEFORE DISCHARGE. ON (B)(6) 2023, THE PATIENT REPORTED VAGINAL MESH EROSION AND HAD BEEN USING VAGINAL ESTROGEN FOR SEVERAL MONTHS. A GENITOURINARY EXAM REVEALED THE MESH SLING WAS PALPABLE UNDER THE VAGINAL SKIN, THOUGH NO BLUE MESH WAS VISIBLE. A CYSTOSCOPY WAS PERFORMED, SHOWING A NORMAL BLADDER AND URETHRA WITH NO MESH EROSION INSIDE THE BLADDER. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED IN STABLE CONDITION. BASED ON CLINICAL FINDINGS AND DISCUSSIONS, THE PATIENT EXPRESSED INTEREST IN COMPLETE SLING EXCISION AND REPLACEMENT TO AVOID STRESS URINARY INCONTINENCE (SUI), PREFERRING NOT TO RETAIN ANY PARTIAL MESH. ON (B)(6) 2023, THE PATIENT UNDERWENT PARTIAL EXCISION AND REVISION OF A

  Patient problems: Abdominal Pain; Dyspareunia; Erosion; Pain; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 22023760 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ADVANTAGE FIT BLUE SYSTEM IMPLANTED DURING A PROCEDURE ON (B)(6) 2023, TO TREAT URINARY STRESS INCONTINENCE. THE SLING WAS POSITIONED TENSION-FREE, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION WITH NO INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS NOTED. HOWEVER, THE PATIENT HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL BURNING, PUDENDAL NEURALGIA, DYSPAREUNIA, CHRONIC PELVIC PAIN, DYSPNEA, YEAST INFECTIONS, VAGINITIS, AND FREQUENT MUSCLE SPASMS. SUBSEQUENTLY, THE PATIENT UNDERWENT EXCISION SURGERY. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO ADDITIONAL SURGERY AND MAY SUFFER FUTURE DAMAGES SUCH AS SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH PERSISTENT GROIN PAIN, MORE PRONOUNCED ON THE LEFT SIDE, WITH INTERMITTENT FLARES SINCE JANUARY. SHE HAD PREVIOUSLY BEEN DIAGNOSED WITH A YEAST INFECTION; HOWEVER, HER SYMPTOMS DID NOT IMPROVE. PRIOR TO THAT, SHE HAD SEEN HER PHYSICIAN IN FEBRUARY, WHO BELIEVED HER PAIN WAS DUE TO

  Patient problems: Abdominal Pain; Burning Sensation; Constipation; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Dyspnea; Dysuria; Inflammation; Micturition Urgency; Movement Disorder; Muscle Weakness/Atrophy; Nerve Damage; Pain; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urethral Stenosis/Stricture; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 22018719 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SECOND ADVANTAGE FIT BLUE SYSTEM WAS IMPLANTED TO TREAT STRESS URINARY INCONTINENCE SYMPTOMS. THIS SECOND DEVICE WAS PLACED AFTER THE PREVIOUS SLING HAD BEEN LOOSENED. AFTER THE IMPLANTATION, THE PATIENT INDICATED EXPERIENCING URINARY INFECTION, INCOMPLETE URINATION, BEING FORCED TO URINATE STANDING UP, DIVERTED URINE STREAM, DYSURIA, CONSTANT PAIN THAT INTENSIFIES WHEN WALKING, AND SENSATIONS SIMILAR TO ELECTRIC SHOCKS AND PERINEAL BURNING. ADDITIONALLY, THE PATIENT NOTED PSYCHOLOGICAL, FAMILY, PROFESSIONAL REPERCUSSIONS AS THE PATIENT HAS NEEDED TO REMAIN ON SICK LEAVE SINCE THE FIRST INTERVENTION. AROUND A MONTH AFTER IMPLANT, URINE SAMPLES WERE COLLECTED AND CULTURED. THE CULTURE PROVIDED A POSITIVE RESULT FOR CITROBACTER FREUNDII, LEADING TO ANTIBIOTICS BEING PRESCRIBED. APPROXIMATELY TWO MONTHS AFTER IMPLANT, A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO LOCATE OR PALPATE THE DEVICE. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS REFERRED TO ANOTHER CENTER TO BE SEEN BY A SPECIALIST. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED ON THE SAME PATIENT. REFER TO MANUFA

  Patient problems: Burning Sensation; Dysuria; Pain; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Retention; Urinary Tract Infection

  MAUDE report 21922473 ↗
• InjuryApr 28, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AN ADVANTAGE FIT BLUE SYSTEM WAS IMPLANTED TO TREAT STRESS URINARY INCONTINENCE SYMPTOMS. IMMEDIATELY AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED ACUTE URINARY RETENTION AND SIGNIFICANT PAIN. SEVERAL STENTS WERE PLACED DURING THE DAYS FOLLOWING THE IMPLANT PROCEDURE; HOWEVER, VOIDING WAS NOT POSSIBLE. THE PATIENT INDICATED EXPRESSING THE DESIRE TO REMOVE THE SLING; HOWEVER, IT WAS NOTED THAT THE MEDICAL PERSONNEL RECOMMENDED LOOSENING THE DEVICE INSTEAD. APPROXIMATELY A WEEK AFTER IMPLANT, THE PATIENT WAS HOSPITALIZED AFTER ATTEMPTING TO LOOSEN THE TIGHT SLING VAGINALLY. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH IT WAS NOTED THAT THE STRIP HAD BECOME EXCESSIVELY LOOSE AND EVENTUALLY CAME OFF; THEREFORE, THE GYNECOLOGIST OPTED TO REMOVE THE EXISTING SLING AND IMPLANT A NEW DEVICE. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-25023 FOR THE SECOND ADVANTAGE FIT BLUE SYSTEM DEVICE.

  Patient problems: Pain; Urinary Retention

  MAUDE report 21922470 ↗
• MalfunctionMar 24, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT BLUE SYSTEM, THE DEVICE WAS DIFFICULT TO ADVANCE CAUSING THE TROCAR TO SLIP BACK. THE DILATOR ARM DETACHED FROM THE TROCAR, AND THE NEEDLE TIP PIERCED THE PLASTIC DILATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678506 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED DURING A RETROPUBIC MID-URETHRAL SLING AND CYSTOURETHROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. DUE TO EXPOSED VAGINAL MESH SLING, VAGINAL PAIN, VAGINAL DISCHARGE, AND VAGINAL BLEEDING, THE PATIENT UNDERWENT RELEASE, EXCISION, EXTRACTION OF EXPOSED VAGINAL MESH SLING, URETEROLYSIS, AND CYSTOURETHROSCOPY ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE SLING WAS TIGHTLY ADHERENT TO THE URETHRA ON THE PATIENT'S LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 20698399 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PLASTIC SHEATH DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949333 ↗
• MalfunctionApr 11, 2024Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT BLUE SYSTEM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(4) 2024, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. DURING PREPARATION, THE BOX WAS OPENED AND FOUND THAT THE PACKAGING OF THE COMPLAINT DEVICE WAS UNSEALED AND WAS UNSTERILE. THE DEVICE WAS THEREFORE UNABLE TO BE USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087546 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UPHOLD VAGINAL SUPPORT SYSTEM DEVICE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DUE TO THE IMPLANTATION, THE PATIENT EXPERIENCED INJURIES INCLUDING PAIN, SEVERE INFECTIONS, MESH EROSION, BLEEDING AND DISCHARGE. SHE ALSO UNDERWENT ADDITIONAL MEDICAL TREATMENT AND PROCEDURES INCLUDING REMOVAL.

  Patient problems: Abnormal Vaginal Discharge; Erosion; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection

  MAUDE report 19057756 ↗
• InjuryApr 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 ADVANTAGE FIT BLUE SYSTEM DEVICE WAS IMPLANTED IN A PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. ADDITIONALLY, DURING THE SAME SURGERY, AN ADDITIONAL CYSTOCELE REPAIR WAS PERFORMED. DURING THE PROCEDURE, A CYSTOSCOPY WAS PERFORMED CONFIRMING CORRECT SLING PLACEMENT AND ABSENCE OF ANY BLADDER PENETRATION. ON (B)(6) 2024, THE PATIENT HAD A FOLLOW-UP MEDICAL APPOINTMENT. DURING CONSULTATION, THE PATIENT INDICATED EXPERIENCING BURNING WHEN URINATING, NOCTURNAL URINARY FREQUENCY AND PAIN FOLLOWING THE SLING PLACEMENT. THE PATIENT NOTED DAY-TO-DAY DIFFICULTIES INCLUDING ASTHENIA AND DAILY VULVAR BURNS. THE PATIENT WAS ADMITTED AT THE PAIN CENTER FOR FOLLOW UP AS ANALGESICS WERE NOT EFFICIENT. IN (B)(6) 2024, THE PATIENT NOTED THAT INFECTIONS AND URINARY INFLAMMATION HAD BECOME MORE FREQUENT UNTIL BECOMING DAILY SYMPTOMS. THE PATIENT ALSO EXPERIENCED VULVODYNIA, PUDENDAL NEURALGIA, BURNING, BLADDER INFLAMMATION. THE PATIENT ALLEGED THE PAIN HAD INTENSIFIED AND PREVENTED HER FROM WALKING AND DRIVING WHICH LED TO ANXIETY. THERE HAVE NOT BEEN ANY FURTHER ACTIONS TAKEN IN THE HEALTH CARE FACILITY

  Patient problems: Anxiety; Dysuria; Inflammation; Micturition Urgency; Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 19050932 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, PARAVAGINAL DEFECT REPAIR WITH GRAFT, POSTERIOR COLPORRHAPHY WITH GRAFT, ENTEROCELE REPAIR, UTEROSACRAL LIGAMENT SUSPENSION, MID-URETHRAL SLING, AND CYSTOSCOPY PROCEDURES PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF UTERINE PROLAPSE, BILATERAL PARAVAGINAL DEFECTS, ENTEROCELE, RECTOCELE, AND STRESS URINARY INCONTINENCE. DESCRIPTION OF PROCEDURE: THE COLPOTOMY WAS THEN BEGUN ANTERIORLY. THIS WAS CONTINUED UNTIL THE CERVIX WAS COMPLETELY SEPARATED FROM THE VAGINA. THE UTERUS CERVIX, AND TUBES, WERE THEN PULLED INTO THE VAGINA, AND THEN REMOVED. ATTENTION WAS THEN TURNED TO THE VAGINAL PORTION OF THE PROCEDURE. THE ENTEROCELE WAS CLOSED REEFING THE PERITONEUM FROM UTEROSACRAL LIGAMENT ON THE RIGHT TO UTEROSACRAL LIGAMENT ON THE LEFT. THE VAGINAL CUFF WAS CLOSED HORIZONTALLY. ATTENTION WAS TURNED TO THE VAGINAL PARAVAGINAL DEFECT PAIR. AFTER INJECTION WITH DILUTE VASOPRESSIN SOLUTION, A VERTICAL INCISION WAS MADE THE ANTERIOR VAGINA FROM THE CUFF TO THE BLADDER NECK. WEAKNESS AND ABSENCE OF FASCIA WAS NOTED. SKIN INCISIONS OF FIV

  Patient problems: Dyspareunia; Erosion; Fecal Incontinence; Pain; Prolapse

  MAUDE report 18749355 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A SYNTHETHIC MID-URETHRAL SLING, ANTERIOR REPAIR, AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AND A STAGE II CYSTOCELE. DURING THE PROCEDURE, CYSTOSCOPY WAS PERFORMED AN NO BLADDER INJURIES WERE OBSERVED, THERE WAS GOOD URETERAL SPILL OF URINE BILATERALLY, AND GOOD SLING PLACEMENT. THERE WAS GOOD HEMOSTASIS AT THE END OF THE PROCEDURE. THE VAGINA WAS IRRIGATED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. IN 2020, THE PATIENT EXPERIENCED EROSION WITH THE SLING DEVICE AND PLANNED TO START A VAGINAL ESTROGEN CREAM; HOWEVER, THE PATIENT COULD NOT RECALL IF THE TREATMENT WAS ATTEMPTED OR NOT. ON (B)(6) 2022, THE PATIENT PRESENTED FOR EVALUATION OF EROSION OF THE SUBURETHRAL SLING AND RECURRENT URINARY INCONTINENCE. THE PATIENT NOTED VAGINAL PAIN WHEN SITTING, PAIN IN URETHRA, DYSURIA, AND DYSPAREUNIA DURING INSERTION. IT WAS NOTED THAT THE MESH EROSION-RELATED SYMPTOMS HAD SIGNIFICANTLY WORSENED SINCE THE LAST APPOINTMENT, AND THE PATIENT TRIED AZO, WHICH WAS SOMEWHAT HELPFUL. T

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Convulsion/Seizure; Dizziness; Dyspareunia; Dysuria; Erosion; Headache; Micturition Urgency; Nausea; Neck Pain; Numbness; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 18735510 ↗
• InjuryJan 18, 2024Adverse 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 IMPLANTED IN SEPARATE PROCEDURES. PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT BLUE SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. EVENT SUMMARY: AT THE BEGINNING OF SEPTEMBER 2019, THE FIRST SYMPTOM THE PATIENT FELT WAS A RAZOR BLADE-TYPE OF PAIN IN HER VAGINA. OPERATIVE REPORT PERFORMED ON (B)(6) 2019: INDICATION: MIXED URINARY INCONTINENCE PREDOMINANT ON EXERCISE WITH SPHINCTER HYPOTONIA AT BUD. NO DYSURIA, NO RPM (REMOTE PATIENT MONITORING). FAILURE OF PELVIC TRAINING. NTVT MESH PROPOSAL. CYSTOSCOPY SHOWS A HEALTHY BLADDER. THE BLADDER EMPTIED WITH THE CATHETER. VAGINAL CLOSURE WITH AN OVERLOCK OF POLYSORB 3/0. OPERATIVE REPORT PERFORMED ON (B)(6) 2019: INDICATION: VAGINAL EXPOSURE OF TVT (TENSION-FREE VAGINAL TAPE) MESH DESPITE SURGICAL REVISION THREE WEEKS AFTER PLACEMENT WITH COLLECTION. TERRAIN AT RISK WITH VAGINAL LICHEN. NO SIGNS OF INFECTION. NO URETHRAL INVOLVEMENT IN FIBROSCOPY, DISABLING SYMPTOMS WITH A PERMANENT RAZOR BLADE SENSATION IN FRONT OF THE EXPOSED PART. PROPOSAL FOR REMOVAL OF THE MESH VAGINALLY AFTER CONSULTAT

  Patient problems: Discomfort; Dysuria; Erosion; Fatigue; Incontinence; Nerve Damage; Pain; Scar Tissue; Unspecified Musculoskeletal problem; Urinary Incontinence; Weight Changes

  MAUDE report 18535044 ↗
• InjuryJan 18, 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. PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT BLUE SYSTEM WAS IMPLANTED INTO THE PATIENT ON DURING A PROCEDURE PERFORMED ON (B)(6) 2019. EVENT SUMMARY: AT THE BEGINNING OF SEPTEMBER 2019, THE FIRST SYMPTOM THE PATIENT FELT WAS A RAZOR BLADE-TYPE OF PAIN IN HER VAGINA. OPERATIVE REPORT PERFORMED ON AUGUST 28, 2019: INDICATION: MIXED URINARY INCONTINENCE PREDOMINANT ON EXERCISE WITH SPHINCTER HYPOTONIA AT BUD. NO DYSURIA, NO RPM (REMOTE PATIENT MONITORING). FAILURE OF PELVIC TRAINING. NTVT MESH PROPOSAL. CYSTOSCOPY SHOWS A HEALTHY BLADDER. THE BLADDER EMPTIED WITH THE CATHETER. VAGINAL CLOSURE WITH AN OVERLOCK OF POLYSORB 3/0. OPERATIVE REPORT PERFORMED ON SEPTEMBER 18, 2019: INDICATION: VAGINAL EXPOSURE OF TVT (TENSION-FREE VAGINAL TAPE) MESH DESPITE SURGICAL REVISION THREE WEEKS AFTER PLACEMENT WITH COLLECTION. TERRAIN AT RISK WITH VAGINAL LICHEN. NO SIGNS OF INFECTION. NO URETHRAL INVOLVEMENT IN FIBROSCOPY, DISABLING SYMPTOMS WITH A PERMANENT RAZOR BLADE SENSATION IN FRONT OF THE EXPOSED PART. PROPOSAL FOR REMOVAL OF THE MESH VAGINALLY

  Patient problems: Discomfort; Dysuria; Erosion; Fatigue; Incontinence; Nerve Damage; Pain; Unspecified Kidney or Urinary Problem; Unspecified Musculoskeletal problem; Urinary Incontinence; Weight Changes

  MAUDE report 18534706 ↗