MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507010

Device Problems Premature Activation (1484); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a mid-urethral sling placement procedure performed on (b)(6) 2023, for the treatment of stress urinary incontinence.This was the physician's second ever solyx case as the first one was only two hours before this event.During the procedure, the physician was experiencing difficulty advancing the trocar.The insertion of the trocar was too shallow, resulting in the trocar being pushed into the inferior pubic ramus.The physician kept pushing and waiting for the pop into the obturator internus muscle, but never felt the pop because she wasn't in the right position for that to happen.The force applied to the trocar when pushing against the bone then caused the trocar tip to bend.The physician attempted to remove the device in order to re-attempt insertion, but the mesh anchor detached from the trocar (prematurely deployed).The mesh was then removed leaving the plastic mesh anchors in place.The procedure was then completed with another solyx sis system device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf device code a040609 captures the reportable event of shaft tip bent.Imdrf device code a150103 captures the reportable event of premature deployment of mesh/carrier assembly.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 16471044
• MDR Text Key: 310558508
• Report Number: 3005099803-2023-00919
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• 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
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068507010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female