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

Model Number M0068505110

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was used during a mid-urethral sling procedure in the urethra, performed on (b)(6) 2024, for the treatment of stress urinary incontinence.During the procedure, when the physician attempted to implant the left side of the sling and pulled out the association loop, it was found that the line broke and the mesh twisted.Another obtryx ii system - halo was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.A photo of the device was provided, showing that the mesh was detached, and the material was twisted and torn.

Manufacturer Narrative

Block h6: imdrf device code a0414 captures the reportable event of mesh torn material.

Manufacturer Narrative

Imdrf device code a0414 captures the reportable event of mesh torn material.Upon receipt at our quality assurance laboratory, this obtryx ii system - halo device underwent a thorough analysis.Visual analysis identified that the mesh was broken in two pieces and was stretched.Additionally, a media was provided and showed that the mesh was broken.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Based on the information available and analysis results, it is likely that procedural conditions, such as user handling technique during placement or advancement of the mesh, resulted in excessive force on the mesh and sleeve, causing the mesh to stretch and separate.A conclusion code of adverse event related to procedure was assigned to this investigation.Date of birth, has been updated based on the additional information received on april 14, 2024.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was used during a mid-urethral sling procedure in the urethra, performed on (b)(6) 2024, for the treatment of stress urinary incontinence.During the procedure, when the physician attempted to implant the left side of the sling and pulled out the association loop, it was found that the line broke and the mesh twisted.Another obtryx ii system - halo was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.A photo of the device was provided, showing that the mesh was detached, and the material was twisted and torn.

• 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: 19113625
• MDR Text Key: 340252645
• Report Number: 2124215-2024-21310
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0031136912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/14/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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 Age: 53 YR
• Patient Sex: Female