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 Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Micturition Urgency (1871); Granuloma (1876); Pain (1994); Scar Tissue (2060); Impaired Healing (2378); Obstruction/Occlusion (2422); Dysuria (2684); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2019, implant date, as no exact event date was reported; however, it was reported that the complications started following her implant procedure.Blocks d4, h4: the complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) md.Block h6: the following imdrf patient codes capture the reportable events below: e2006 - sling erosion/extrusion.E2330 - pain.E2328 - urethral stones.E2015 - friable tissue caused by granulation tissue and mesh extrusion/erosion.E1715 - granulation tissue.E1301 - dysuria.E2314 - fistula.E1715 - scar tissue.E1707 - impaired healing.E230901 - calcifications.The following imdrf patient codes capture the reportable events below: f1903 - removal of midurethral sling being completely exposed and extruded.F1901 - complex urethroplasty, removal of stones, fistula repair.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted into the patient during a transobturator midurethral sling placement procedure performed on (b)(6) 2019 for the treatment of stress urinary incontinence (sui).On (b)(6) 2022, the patient underwent cystourethroscopy, excision of eroded and extruded mid urethral sling, removal of the stones and complex urethroplasty with local tissue mobilization and interposition with biological graft.The patient alleged having pain, burning and difficulty with voiding for months prior to the revision.During cystoscopy, it was noted that the urethra was significantly narrowed due to the sling transversing in the middle with calcifications on it.It was detailed that the physician had difficulty passing a 17 french cystoscope due to the narrowing.Examination under anesthesia revealed that the sling was completely exposed and extruded from one endopelvic to the other in the pelvic sidewall extending all the way to the right obturator fossa.It was noted that a part of the urethra was missing due to this 3cm erosion/extrusion of the sling.There was a significant 2 cm x 1 cm defect in the urethra that the foley catheter was easily visualized vaginally suggesting a fistula.The area was granulomatous and friable due to granulation tissue caused by the sling erosion and extrusion.The right side of the sling was entering the obturator canal and was not healed as urine was tracking into it.During surgery, the sling was separated from the surrounding tissues, excised, and removed.The ureter was repaired obtaining a watertight repair, and a repeated cystoscopy did not show bladder injuries.A biological graft was done, and the vaginal mucosa was reconstructed.On (b)(6) 2022, the patient underwent cystoscopy, exam under anesthesia, complex urethrovaginal fistula repair, urethroplasty, harvest of rectus abdominal fascia and placement of pubovaginal sling procedures.Following the removal of the sling in (b)(6) 2022, the patient returned for a follow-up visit for cystoscopy with a well-healed repair; however, she still had complaints of incontinence and underwent a video urodynamic study (vuds), which revealed evidence of sui.It was then decided to proceed with a rectus fascia pubovaginal sling based on findings from the previous surgery.The main risks of the sling were discussed, including the possibility of her overactive bladder (oab) persisting or worsening.During the procedure, cystourethroscopy showed normal bladder mucosa, a well healed urethra, no foreign bodies, stones, or remaining mesh.An urethrocutaneous fistula was seen on the anterior wall which was repaired before continuing with the pubovaginal sling.There were no further patient complications reported.

• 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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17836228
• MDR Text Key: 324505055
• Report Number: 3005099803-2023-05179
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female