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

Model Number M0068504000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an obtryx system - curved was used during a transobturator mid-urethral sling procedure performed on (b)(6) 2023.During the procedure, the physician inserted a needle through the obturator membrane and vaginal incision.A loop was attached to the distal end of the needle and pulled back the needle through the skin; however, the blue dilator came loose from the mesh assembly.They managed to grab the mesh and pull it through the skin.The procedure was completed using the same device.There were no patient complications as a result of the event.

Manufacturer Narrative

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

• 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: 18209113
• MDR Text Key: 329003409
• Report Number: 2124215-2023-65665
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K040787
• 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
• Report Date: 11/27/2023

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: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0032074543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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