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 Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 01/18/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an solyx sis system device was implanted into the patient during a suburethral sling placement using the solyx sling system with intraoperative cystoscopy performed on (b)(6) 2017, for the treatment of genuine stress urinary incontinence.During the procedure, the patient was noted to have rotational descent of the urethrovesical angle, and on cystoscopy, normal bladder anatomy was noted with no intrusion into the bladder.Furthermore, the operative site was copiously irrigated and floseal was placed due to above-average bleeding.Other than this, there were no complications noted throughout the procedure.The procedure was well tolerated by the patient, who was taken to the recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury as a result of the surgery.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2017 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 representation.The implanting physician is: (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 sought for a legal recourse for injuries related to the device.F23 - a floseal was used to treat the bleeding.

• 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: 16761576
• MDR Text Key: 313501199
• Report Number: 3005099803-2023-01882
• 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: 04/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0019226632
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Female