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

Model Number M0068507000

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a sling procedure performed on (b)(6) 2020 to treat stress urinary incontinence.According to the complainant, during the procedure, the mesh did not release from the shaft tip inside the patient.The procedure was completed with another solyx sis system device.There were no patient complications as a result of this event.The condition of the patient after the procedure was reported to be good.

Manufacturer Narrative

Block h6: device code 1158 captures the reportable event of mesh failed to deploy.A visual examination of the returned solyx single incision sling (sis) revealed that the mesh assembly had both carriers attached.One end of the mesh had residue on the mesh material and carrier, and the mesh on this side appeared stretched.There was residue on the shaft of the delivery device and the deployment mechanism was damaged.A functional examination found that each carrier could be loaded and deployed from the deployment mechanism; the reported issue of mesh failed to deploy was not confirmed.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that it is likely that procedural factors such as debris in the dissection pathway could have contributed to the difficulty advancing the device through the dissection pathway leading to the mesh and delivery damage, and ultimately interfered with the deployment of the device.Therefore, the investigation concluded that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reportred to boston scientific coporation that a solyx sis system device was used during a sling procedure performed on (b)(6) 2020 to treat stress urinary incontinence.According to the complainant, during the procedure, the mesh did not release from the shaft tip inside the patient.The procedure was completed with another solyx sis system device.There were no patient complications as a result of this event.The condition of the patient after the procedure was reported to be good.

• 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
• MDR Report Key: 10399697
• MDR Text Key: 202769471
• Report Number: 3005099803-2020-03127
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0024763535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1