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

Model Number M0068507000

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 solyx sis system device was used during a sling for uterine suspension procedure performed on (b)(6) 2020 for the treatment of uterine prolapse and leakage of urine.According to the complainant, during the procedure, the mesh detached from the mesh carrier while fixing the device into the obturator.The detached mesh was reported to be left inside the patient and had to be removed.The procedure could not be completed due to the device problem; however, it is planned to reschedule the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that solyx sis system device was used during a sling for uterine suspension procedure performed on june 18, 2020 for the treatment of uterine prolapse and leakage of urine.According to the complainant, during the procedure, the mesh detached from the mesh carrier while fixing the device into the obturator.The detached mesh was reported to be left inside the patient and had to be removed.The procedure could not be completed due to the device problem; however, it is planned to reschedule the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1 initial reporter facility name: (b)(6).Block h6: problem code 3191 is being used to capture the reportable issue of cancelled procedure.A visual examination of the returned solyx sis system revealed that both mesh carriers were detached from the mesh and were not returned; confirming the reported complaint.Additionally, there was a damage of the mesh material and there was residue present on it.The geometry of the material showed evidence of being stretched.There was a residue on the delivery device.No damage to the shaft and handle were noted.There was a slight bend in the delivery device tube, indicative of compression.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 the sling detached during placement in the obturator.It is likely the procedural factors such as procedural debris in the dissection pathway, contributed to the user experiencing difficulty advancing the mesh carrier to the target anatomy, and exerting excessive force resulting in the tearing and stretching of the mesh material and the carrier detachment.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 event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 10282043
• MDR Text Key: 199751842
• Report Number: 3005099803-2020-02705
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0024120212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 58