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 Problem (3009)

Patient Problems Scar Tissue (2060); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019, the date the sling was removed, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a solyx single incision sling system was implanted during a total vaginal hysterectomy, anterior repair, paravaginal defect repair bilateral, bilateral sacrospinous ligament fixation, perineoplasty, and solyx procedure performed on (b)(6) 2017, for the treatment of pelvic organ prolapse and urinary incontinence.On (b)(6) 2019, the patient had voiding dysfunction and a recurrent urinary tract infection.The findings showed a tight sling and a scarred anterior vaginal wall.During the procedure, the sling was palpated quite tight around the mid-urethra and this was carefully circumferentially dissected off the mid-urethra, cut in the middle, and then dissected completely as it inserted into the obturator internus muscle bilaterally.There, it was cut and sent for pathological analysis.The patient tolerated the procedure well and was returned to the recovery room in good condition.

• 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
• 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: 15353589
• MDR Text Key: 299273719
• Report Number: 3005099803-2022-05044
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2022

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 Expiration Date: 12/07/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0020050218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female