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 Insufficient Information (4580)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for an unspecified personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a robotic-assisted laparoscopic hysterectomy, bilateral salpingectomy, cystoscopy, and mid-urethral sling placement procedure performed on (b)(6) 2016, for the treatment of abnormal uterine bleeding, anemia, and pelvic pain.During the exam under anesthesia, it was observed that the uterus was slightly enlarged and in a globular shape.It was found to be mobile and anteverted.No masses were detected in the surrounding areas.The laparoscopic findings showed a similar enlarged globular uterus, but both fallopian tubes and ovaries appeared normal.The liver edge was also normal, but the gallbladder was slightly enlarged.After the cystoscopy, it was confirmed that bilateral ureteral jets were present, and there was no damage or suture on the bladder.In addition, the patient underwent the procedure without any issues and was successfully awakened from anesthesia.Afterward, she was moved to the recovery area and remained in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• 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: 17426921
• MDR Text Key: 320120745
• Report Number: 3005099803-2023-04056
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0019399953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female