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

Model Number M0068504000

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

Patient Problems Erosion (1750); Pain (1994)

Event Date 07/17/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - curved was implanted into the patient during a tension-free vaginal tape obturator sling procedure performed on (b)(6) 2012, for the treatment of stress urinary incontinence.Cystoscopy was performed and showed no bladder injury.The patient was in stable and good condition.On (b)(6) 2023, the patient was diagnosed with erosion of bladder suspension mesh and vaginal discharge.During surgery, allis clamps were used to grasp the vaginal epithelium on either side of the exposed mesh.A tonsil was placed between the urethra and the exposed mesh.The approximately one and a half centimeters area of mesh was excised sharply with metzenbaum scissors.Cystourethroscopy was completed, identifying there was mild bladder trabeculations present; otherwise, the bladder was normal.The urethral mucosas with efflux of urine were noted from each ureteral orifice.Following the procedure, the patient was transferred to the post anesthesia care unit in stable condition.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as a best estimate based on the date of mesh removal.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006 - mesh erosion.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.

• Brand Name: OBTRYX SYSTEM - CURVED
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18882385
• MDR Text Key: 337404766
• Report Number: 2124215-2024-14183
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female