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 Detachment of Device or Device Component (2907)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable code of dilator detachment.

Event Description

It was reported to boston scientific that an obtryx ii system - halo was used during a procedure performed on (b)(6), 2023.During the procedure, the device broke apart where the mesh meets the trocar at the plastic sheath.The procedure was completed with another of the same device.There were no patient complications as a result of the event; however, this has caused extra time in the operation room.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable code of dilator detachment.Block h10: investigation summary: with all the available information, boston scientific concludes that the reported events of "difficult/unable to position/tension mesh" with hazardous situation center tab separates from mesh during positioning/tensioning were defined in the risk documentation.During the product analysis visual inspection of the returned device identified the mesh assembly was broken, the mesh was separated from the center tab in addition the mesh had signs of stretching.The reported complaint was confirmed.Investigation conclusion: after the product analysis, it was determined that the mesh assembly was broken, the mesh was separated from the center tab in addition the mesh had signs of stretching.It is likely that procedural conditions, such as user handling technique during placement or advancement of the device, resulted in excessive force on the mesh causing it to stretch leading to its removal from the leader loop and causing the center tab to detach from the mesh.Since the adverse events occurred during the procedure and the device had no influence on event, the most probable cause of adverse event related to procedure is selected, and this is the most probable cause assigned to the reported event overall.A labeling review was performed, and, from the information available, this device was used per instructions for use (ifu)/ product label.

Event Description

It was reported to boston scientific that an obtryx ii system - halo was used during a procedure performed on (b)(6) 2023.During the procedure, the device broke apart where the mesh meets the trocar at the plastic sheath.The procedure was completed with another of the same device.There were no patient complications as a result of the event; however, this has caused extra time in the operation room.

• 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: 18278846
• MDR Text Key: 329868851
• Report Number: 2124215-2023-67256
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: 0031487331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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