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

Model Number M0068505000

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Block d4, h4: the lot number (26829002) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block e1: this event was reported by the patient's legal representation.The implant surgeons are: (b)(6).Block h6: imdrf patient codes e172001, e2330, e1002, e1715, e2401, e1906 and e1405 capture the reportable events of perirectal abscess, pelvic pain, rectal pain, physical pain, abdominal pain, scarring, physical impairment, infections and dyspareunia.

Event Description

*note: this manufacturer report pertains to the first of two devices implanted during different procedures.Refer to manufacturer report number 3005099803-2023-03273 for obtryx system - halo device.It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on october 3, 2017.After the procedure, the patient claimed to have experienced dyspareunia, infections, pelvic pain, abdominal pain, perirectal abscess, rectal pain, scarring, and bleeding, physical pain, physical impairment and mental anguish.

Event Description

*note: this manufacturer report pertains to the first of the two devices implanted in the same patient during different procedures.Refer to manufacturer report number 3005099803-2023-03273 for lynx system device implanted on (b)(6) 2021.It was reported to boston scientific corporation that an obtryx system halo device was implanted into the patient during a vaginal hysterectomy scope total, salpingectomy, anterior and posterior repair with perineoplasty, enterocele repair, bladder sling female, transobturator tape (tot), cystoscopy, vaginal suspension, sacrospinous vault procedure performed on (b)(6) 2017.The patient was diagnosed with menometrorrhagia, dysmenorrhea, pelvic pain, symptomatic pelvic floor relaxation, and type 2 stress urinary incontinence, as demonstrated by urodynamic studies.After the procedure, the patient claimed to have experienced dyspareunia, infections, pelvic pain, abdominal pain, perirectal abscess, rectal pain, scarring, bleeding, physical pain, physical impairment, and mental anguish.On august 23, 2021, the patient was admitted for the chief complaint of stress urinary incontinence with intrinsic sphincter deficiency.She had complications after hysterectomy repairs and sling placement surgery in 2017 and had several gynecological problems afterward, including pelvic pain, dyspareunia, urinary incontinence, rectocele, and adhesions.The patient was seen for urodynamic testing and found to have urethral hypermobility with stress urinary incontinence and a maximum urethral pressure of 95 with a maximum urethral closure pressure of 70 with borderline intrinsic sphincter deficiency (isd).The patient was interested in correcting her problems and wanted to have a sling revision at that time.During the physical examination, the external genitalia were normal aside from a torn labia from prior delivery.The patient also had a large and bulging rectocele, a gaping introitus with a hypermobile urethra, and ureterovesical (uv) junction laxity.The uterus was absent, but she was tender at the apex of her vagina with palpation, and no adnexal masses could be appreciated.On (b)(6) 2021, a lynx system device was implanted into the patient during a transobturator tape sling placement procedure.Additionally, the patient also underwent laparoscopy, rectocele repair, colporrhaphy, combined anterior-posterior perineoplasty, salpingectomy, bladder sling removal, cystoscopy, and removal of the right labia minora remnant.During the procedure, an exam under anesthesia revealed a bulging rectocele and a gaping introitus.Prior to the transobturator tape (tot) procedure, the underlying mid-bladder area was palpable.However, it was not exposed.The physician then used a right-angle clamp behind the sling to dissect it further and cut it at the pubic bone.The physician then removed the underlying tissue attached to the sling all the way over to the other pubic bone and cut it near the pubic bone.There was no injury to the bladder with this, and there was no graft exposure in either the bladder or the vaginal mucosa.The physician then reapproximated the vaginal mucosa in this area, placed surgiflo underlying the mucosa for hemostasis, and then turned attention to the placement of the retropubic sling.Furthermore, the other compartment for the placement of a new sling was opened, and a sling was placed.The sling was noted to be tension-free under the mid-urethra.A cystoscopic examination of the bladder revealed a normal bladder with good efflux of urine bilaterally.The cystoscope was removed, and the foley catheter was replaced.The patient had a small remnant of a tear on her right labia minora, which was twisted and irritated, causing dyspareunia and an intrinsic sphincter deficiency.So, the physician injected the base, cut off the small piece of labia minora, and an excellent result was achieved.The pathological results showed a segment of fibrous tissue with indwelling foreign material (removed bladder sling), a segment of squamous epithelium (labia), squamous mucosa with associated fibroepithelial polyps, and a segment of skin (posterior vagina).

Manufacturer Narrative

Additional information: blocks a2 (date of birth), b2 (outcomes attrib to adv event), b5, b7, d6b (explant date), e1 (healthcare facility address and phone number) and h6 (patient and impact codes) were updated based on the additional information received on june 21, 2023.Block b3 date of event: date of event was approximated to october 3, 2017, implant date, as no event date was reported.Block d4, h4: the lot number (7095562) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block e1: this event was reported by the patient's legal representation.The implant surgeons are: dr.(b)(6).(b)(6) medical center, 1155 mill street, reno, nv 89502-1576, phone number: (b)(6).Block h6: imdrf patient codes e2006, e2330, e1002, e1405, e1715, e2101, e1906, e172001, e0506, and e0206 capture the reportable events of erosion (palpable transobturator tape under the mid-bladder area), pelvic pain, rectal pain, physical pain, abdominal pain, dyspareunia, scarring, adhesions, infections, perirectal abscess, bleeding, physical impairment, and mental anguish.Imdrf impact code f1903 capture the reportable event of device explantation.Block h11: correction: block b5 has been corrected: the first device implanted into the patient on october 3, 2017 is an obtryx system halo device, and the second device implanted into the patient on august 24, 2021 is a lynx system device.

• Brand Name: OBTRYX 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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17170863
• MDR Text Key: 317630259
• Report Number: 3005099803-2023-03272
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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 Model Number: M0068505000
• Device Catalogue Number: 850-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Female