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

Model Number M0068507000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

There is no information available regarding the specific date of when the dehiscence occurred.However, it was mentioned that the event happened a couple of weeks after the implantation of the device.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Captures the reportable event of dehiscence.The complainant indicated that the device is implanted and the device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx mesh was implanted during a mid-urethral sling procedure performed on an unknown date.According to the complainant, a couple of weeks after the procedure, it was noticed that the incision had dehisced exposing the mesh.The patient was then taken back to the or to repair the incision.It was reported that the patient was fine with no reported complications.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

There is no information available regarding the specific date of when the dehiscence occurred.However, it was mentioned that the event happened a couple of weeks after the implantation of the device.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is implanted and the device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx mesh was implanted during a mid-urethral sling procedure performed on an unknown date.According to the complainant, a couple of weeks after the procedure, it was noticed that the incision had dehisced exposing the mesh.The patient was then taken back to the or to repair the incision.It was reported that the patient was fine with no reported complications.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on september 18, 2018.The dehiscence was discovered during the patient's one week routine follow-up.

• 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: 7862818
• MDR Text Key: 119785640
• Report Number: 3005099803-2018-60354
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 73020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention