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); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

(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

This manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that two solyx sis system devices were used during a urethral sling procedure performed on (b)(6) 2020 to treat incontinence.According to the complainant, during the procedure, the mesh carrier detached from the mesh inside the patient.A second device was opened and the same issue occurred.The procedure was cancelled and there is no current plan 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 fine.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that two solyx sis system devices were used during a urethral sling procedure performed on (b)(6) 2020 to treat incontinence.According to the complainant, during the procedure, the mesh carrier detached from the mesh inside the patient.A second device was opened and the same issue occurred.The procedure was cancelled and there is no current plan 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 fine.Additional information received on august 4, 2020--- the detached mesh carrier was not removed from the patient.An attempt was made but it was too deep in the anatomy.

Manufacturer Narrative

Additional information: blocks b5 and h6 patient code have been updated based on the clarification received from the customer.Block h6: problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.

• 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: 10342072
• MDR Text Key: 202916291
• Report Number: 3005099803-2020-02938
• 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: 08/31/2020

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 Expiration Date: 10/23/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0024652927
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR