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); Scar Tissue (2060)

Event Date 08/21/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a total vaginal hysterectomy (tvh) with bilateral salpingo-oophorectomy (bso) + cystoscopy + bladder suspension/sling procedure performed on (b)(6) 2019, due to symptomatic uterovaginal prolapse and genuine stress urinary incontinence.Findings showed atrophic appearing ovaries, hulka clips on tubal remnant, and postmenopausal uterus.The patient was taken out of the dorsal lithotomy position and brought to the recovery room in good condition.On (b)(6) 2021, the patient underwent revision surgery due to mesh erosion.Findings reported 1.5cm portion of the sling eroded that has epithelialized behind it.The portion of the sling was excised and sent to pathology.The patient tolerated the procedure well and was brought to recovery in good condition.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2019, the implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant and revision surgery surgeon is: (b)(6).Block h6: imdrf patient codes e2006 and e1715 capture the reportable event of portion of the mesh eroded that has epithelialized behind it.Imdrf impact code f1905 captures the reportable event of mesh excision surgery.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17969579
• MDR Text Key: 326120319
• Report Number: 3005099803-2023-05605
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0023970066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female