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 Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Dysuria (2684)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The device revision surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted during a solyx single incision placement and cystoscopy procedure performed on (b)(6) 2015 for the treatment of stress urinary incontinence.Following the implantation, the patient experienced postoperative complications such as pelvic pain, recurrent urinary tract infections, and mesh erosion at the bladder neck with adherent calcification.She was reportedly too sensitive to be examined in the office and/or scoped.Furthermore, while the patient was sedated, a cystoscopy with a bilateral retrograde pyelogram and laser fulguration of the exposed mesh at the bladder neck and stone was done on (b)(6) 2020.A 21-frenchrigid scope was readily inserted throughout the procedure.Unremarkable was the urethra.There was a distinct 1 cm stone adhered to the overlying mesh at the bladder neck upon entry.The surgeon was able to remove it with the aid of a grasper; he then took it out and submitted it for analysis.Additionally, a urine culture was collected.Other than the area of the exposed mesh, which was roughly a centimeter from 7-8 o'clock at the bladder, panendoscopy with a 30-degree and 70-degree lens revealed no other anomalies.The surgeon next used a cone-tipped catheter to perform a retrograde pyelogram.The following hour was spent by him lasering the exposed mesh and the still-adhesive calcification on top of it using a 200 micron fiber.Although it was stated that it was exceedingly difficult given the placement, the surgeon took great care to avoid damaging the good tissue.At the conclusion of the case, the surgeon did not notice any additional exposed fibers.A 16-french foley catheter was inserted after the patient's bladder was drained.According to reports, the patient handled the procedure well.She was easily awakened and then moved in good condition to the recovery room.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15454805
• MDR Text Key: 300226581
• Report Number: 3005099803-2022-05359
• 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: 09/20/2022

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: 02/28/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00002871
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female