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

Model Number M0068505110

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Anemia (1706); Bruise/Contusion (1754); Diarrhea (1811); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Paralysis (1997); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Malaise (2359); Deformity/ Disfigurement (2360); Depression (2361); Numbness (2415); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Constipation (3274); Movement Disorder (4412); Paresthesia (4421); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521); Localized Skin Lesion (4542); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The event date was approximated to (b)(6) 2020, implant date, as no event date was reported.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported that to boston scientific corporation an obtryx ii system - halo was implanted during a procedure performed on (b)(6) 2020.As reported by the patient's attorney, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Additional information to blocks b2: outcomes attrib to adv event, b5, e1 and h6: patient codes block b3: the event date was approximated to (b)(6), 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.Additional attorneys for the patient: (b)(6) implanting healthcare facility & address: (b)(6) block h6: patient codes e2308, e1906, e0402, e2330, e1002, e1311, and e2401 capture the reportable events of disfigurement, infection, foreign body reaction, pelvic pain, groin pain, leg pain, abdominal pain, urinary problems, and difficulty walking respectively.Impact codes f1202 and f19 capture the reportable events of disability and additional surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a procedure performed on (b)(6), 2020.Post procedure, the patient experienced the following injuries as a result of the implantation: abdominal pain; pelvic pain; groin pain; leg pain; infection; recurrence of prolapse; recurrence of incontinence; urinary problems; difficulty walking, and discharge.In addition, the patient also had chronic complications of mesh, including inflammation, foreign body reaction, and surgical revision/removal.Reportedly, the patient is still receiving treatment.Furthermore, the patient have suffered the following damages as a result of the implantation of the mesh: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future emotional distress, and past and future physical pain and suffering.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a cystoscopy, hydrodistention of the bladder, pubovaginal sling placement, and removal of interstim pacemaker and lead procedure performed on (b)(6), 2020 for the treatment of interstitial cystitis, stress urinary incontinence (sui), and nonfunctional bladder pacemaker with battery depletion.Over five years ago, she had placement of an interstim pacemaker by another physician.The device was no longer functioning due to battery depletion.She did not want to have the battery changed, but she wanted to have the device removed entirely.Finally, when the cystoscopy was performed on her, she had bladder inflammation consistent with interstitial cystitis.Cultures showed no growth.She had symptoms of interstitial cystitis which also consist of suprapubic and pelvic pains as well as urinary urgency and frequency.She was given ancef 2 grams intravenously on call in the operating room.During the procedure, it was also observed that the previous pubovaginal sling had resulted in some sub-urethral scarring of the vaginal mucosa and there was a bladder inflammation.Post procedure, the patient experienced the following injuries as a result of the implantation: abdominal pain; pelvic pain; groin pain; leg pain; infection; recurrence of prolapse; recurrence of incontinence; urinary problems; urinary urgency, difficulty walking, and discharge.In addition, the patient also had chronic complications of mesh, including inflammation, foreign body reaction, and surgical revision/removal.Reportedly, the patient is still receiving treatment.On (b)(6), 2020, the patient presented leg pain, neuropathic pain, hip pain, numbness, tingling, and nausea.After the sling procedure, she had unilateral pain in the right leg that was continuous, stabbing pain that led to her having difficulty lifting her leg.Also, she experienced weakness, restless legs, gait dysfunction, and paralysis.The patient stated that her symptoms have been worsening.On (b)(6), 2020, she had a consultation for her groin abscess after the mid-urethral sling.The patient presented overnight to the emergency room (er) with a complaint of worsening right groin and leg swelling, with purulent drainage from her right groin incision, and tender on palpation.Also, there was erythema of 2-3cm induration, and compression of this area results in purulent drainage from the 1cm groin incision.She noted that she developed excruciating pain postoperative day 2 from surgery, since that time it did not improve, and only got worsened.She mentioned that she had subjective fevers at home.The ct scan in the er showed 2 loculated fluid collections in the right anterior thigh measuring 4-1/2 and 2 cm.She stated that she already was scheduled for excision of the infected mesh on tuesday in atlanta if she is healthy enough to travel.On (b)(6), 2020, the patient had drainage of 30cc of purulent material yesterday and stated that she's sore from the drain placement.On (b)(6), 2020, she underwent excision of infected mid-urethral sling and cystoscopy procedure.The exposed vaginal portion of mid-urethral sling was removed from the right side and the dissection on the left side revealed exposure of purulent material then complete excision of the implanted mesh.Cystourethroscopy was then performed at that time and showed no injury to the urethra.On (b)(6), 2020, the patient reported that her joint pain and severe headache were worsening.On (b)(6), 2020, she mentioned that she was diagnosed with a disorder of vitamin b12 and iron deficiency anemia.On (b)(6), 2020, she was 6 weeks status post excision of the infected mid-urethral sling and was emptying bladder with no concerns.On (b)(6), 2021, the patient was in for vaginal complaints, lesion, arthralgias/joint pain, back pain, and condyloma acuminata of vulva.On (b)(6), 2021, she had a history of restless legs, and insomnia.She was in for follow-up and reported that her restless legs syndrome was worsening.Furthermore, the patient have suffered the following damages as a result of the implantation of the mesh: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future emotional distress, and past and future physical pain and suffering.

Manufacturer Narrative

Block a4: patient's weight: 182.6 lbs.Block b3: the event date was approximated to (b)(6), 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.Additional attorneys for the patient: (b)(6).Implanting healthcare facility & address: (b)(6) hospital (b)(6).Dr.(b)(6) (attending physician).Dr.(b)(6) (anesthetist).Dr.(b)(6) (ob/gyn).Dr.(b)(6).Dr.(b)(6) (pathology).Dr.(b)(6).Dr.(b)(6) (sleep medicine).Dr.(b)(6) (neurologist).(b)(6).Dr.(b)(6) (general surgeon).(b)(6).Dr.(b)(6) (urologist).(b)(6).Dr.(b)(6) (primary care provider).(b)(6).Dr.(b)(6) (urogynecology).(b)(6).(b)(6)medical center - (b)(6).(b)(6).(b)(6).Block h6: patient codes e2308, e1906, e0402, e2330, e1002, e1311, e2401, e2326, e0123, e0126, e1715, e1310, e1309, e0506, e2002, e1302, e172001, e012202, ee020201, e0130, e1710, and e0301, capture the reportable events of disfigurement, infection, foreign body reaction, pelvic pain, groin pain, leg pain, abdominal pain, urinary problems, difficulty walking, inflammation, nerve damage, neuropathy, scar tissue, urinary tract infection, urinary retention, hemorrhage/bleeding, brusie/contusion, hematuria, abscess, paralysis, anxiety, depression, sleep dysfunction, localized skin lesion, and anemia.Impact codes f1202, f19, f1903, f2303, and f22 capture the reportable events of disability, excision of infected mid-urethral sling, ancef 2 grams, cystoscopy, cystourethroscopy, and ct scan.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: OBTRYX II SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10710961
• MDR Text Key: 212315534
• Report Number: 3005099803-2020-04580
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0025365227
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 05/25/2021; 01/14/2022
• Supplement Dates FDA Received: 06/22/2021; 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female