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 Erosion (1750); Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Scar Tissue (2060); Urinary Incontinence (4572)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as the best estimate based on the revision date.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: imdrf patient code e2006 captures the reportable event of mesh erosion through the middle of the urethra.Imdrf patient code e1715 captures the reportable event of mesh small remnants of the mesh.Imdrf patient code e1304 captures the reportable event of mesh urge urinary incontinence.Imdrf patient code e232402 captures the reportable event of worsening stress urinary incontinence.Imdrf patient code e230901 captures the reportable event of visible band of mesh with small calcifications.Imdrf impact code f1901 captures the reportable event of cystoscopy and urethroplasty procedure.Imdrf impact code f1905 captures the reportable event of part of urethral mesh sling revision and piece of mesh from urethral lumen removal.

Event Description

It was reported to boston scientific corporation that an obtryx system-halo device was used during a trans obturator tape procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence.On (b)(6) 2022, the patient was diagnosed with mixed stress, urge urinary incontinence, and erosion of the implanted urethral mesh into surrounding tissue.She then underwent a urethroplasty, an exam under anesthesia, revision or removal of the vaginal mesh, a cystoscopy, and revision of the urethral sling.During the procedure, it was noted that it was very difficult to locate the mesh due to the depth of the embedded mesh.On the lateral aspect of the vagina, they were able to palpate a deep band that corresponded to the mesh, but not in a normal location.During the cystourethroscopy procedure, the mesh appeared to protrude from the dorsal mid-urethra.Since it was difficult to find the mesh planes in the vagina, a cystoscopy was then performed to assess the excision.Small remnants of the mesh alongside the left and right lateral walls of the urethra were found.These were minor remnants that were deeply embedded within the wall of the urethral.The patient tolerated the procedure well, was extubated in the operating room, and was taken to the recovery room in stable condition.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17817310
• MDR Text Key: 324250186
• Report Number: 3005099803-2023-05029
• 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
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0022898596
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female