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); Fistula (1862); Unspecified Infection (1930)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of march 28, 2023, was chosen as the best estimate based on the day of admission; the revision happened the day after.Block h6: imdrf patient code e2006 captures the reportable event of mesh erosion.Imdrf patient code e2314 captures the reportable event of colovaginal fistula.Imdrf patient code e1906 captures the reportable event of recurrent infections.Imdrf impact code f19 captures the reportable event of removal of the visible mid-urethral sling.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was used during a total abdominal hysterectomy with right salpingectomy, panniculectomy, trans-obturator sling placement, and post-procedure performed on (b)(6) 2020.On (b)(6) 2023, the patient presented recurrent vaginal infections and a possible colovaginal fistula.A surgical procedure was performed in which approximately 2 cm of exposed mesh were identified on the left lateral aspect of the vagina.The patient underwent the removal of the visible mid-urethral sling.Additionally, during the procedure a fistula was identified tracking from the left lateral vagina to the buttock.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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19042545
• MDR Text Key: 339431825
• Report Number: 2124215-2024-19177
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 03/12/2024
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female