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

Model Number	M0068507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2019, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).The sling excision surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: imdrf patient code e2328 captures the reportable event of bladder obstruction.The following imdrf impact codes capture the reportable events of: imdrf impact code f1905 captures the reportable event of removal of the sling.
Event or Problem Description
It was reported to boston scientific corporation that a single incision sling device was implanted into the patient during a mid-urethral sling with prolene mesh placement and cystoscopy procedure performed on (b)(6) 2019, for the treatment of stress incontinence.During the procedure, a cystoscopy was performed, and there was no injury to the bladder.The trigone was normal, and urine was seen to spill from each ureteral orifice.The patient was taken to the recovery room in stable condition.The patient had a bladder obstruction after the sling was implanted.On (b)(6) 2022, the patient had the vaginal mesh removed and urethrolysis performed.During the surgery, a cystourethroscopy was performed, which indicated a normal bladder with no signs of a stone mass lesion, carcinoma in situ, foreign body injury, or trauma to the bladder or urethra.Ureteral orifices were in their normal anatomic location, effluxing clear urine bilaterally.

• Brand Name: SOLYX SIS SYSTEM
• Common Device Name: 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: 17762510
• Report Number: 3005099803-2023-04956
• Device Sequence Number: 12506745
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0023421804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female