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 Problems Abscess (1690); Erosion (1750); Pain (1994); Scar Tissue (2060); Dyspareunia (4505)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.(b)(4).The complaint 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 sis system was implanted into the patient during a laparoscopic left salpingo-oophorectomy, anterior colporrhaphy, paravaginal suspension; suburethral sling, posterior colporrhaph, perineorrhaphy, sacrospinous ligament fixation, lysis of adhesions, cystoscopy, suprapubic catheter, trachectomy procedures performed on (b)(6) 2018.After the procedure, the patient had experienced dyspareunia, vaginal scarring and pain.On (b)(6) 2021, the patient underwent a removal of suburethral sling.During the procedure, the suburethral sling was palpated and an erosion was visualized at the right portion of the proximal urethra.An approximately 2 cm segment of sling was then incised and removed from the right urethra.Reportedly, a purulent fluid was noted and a suburethral cyst drainage was also performed on the patient.The incision was then closed with 2-0 vicryl in an interrupted fashion in two layers.The patient was transferred to the recovery room in stable 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: 12377053
• MDR Text Key: 268450293
• Report Number: 3005099803-2021-04316
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0021806511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 47