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 03/05/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system was used during a transvaginal tape, excision of vaginal mesh, cystourethroscopy and posterior repair procedure performed on (b)(6) 2013 to treat a patient with stress urinary incontinence, vaginal prolapse, and exposed vaginal mesh in the posterior compartment.During the procedure, under general anesthetic with foley catheter in place, a weighted speculum was placed and the anterior compartment was seen to be relatively well supported.The vaginal mucosa was grasped approximately 1 cm beneath the urethral orifice, infused with marcaine and a small incision made.A tunnel was created through the obturator foramen bilaterally into which solyx transvaginal tape was placed without difficulty.Tape was brought into appropriate tension without contacting the inferior surface of the urethra and the vaginal defect closed with a running, locked #2-0 vicryl suture.Cystourethroscopy was next performed which showed clear efflux of indigo carmine from both uteric orifices without any intracystic damage or evidence of prolene of any kind.Foley catheter was replaced and attention was turned posteriorly.A rectal exam was performed which showed no rectal involvement of mesh.Marcaine was infused in the perineal body which was excised, and the retrovaginal septum developed to the region of mesh exposure.Rectal digit was again placed and with the mesh under slight traction, the exposed mesh was removed and submitted to pathology.No other palpable mesh was present, and at this point the perineal body was rebuilt with a #2-0 vicryl sutue and the remaining defect closed with a running, locked #2-0 vicryl repeat.Hemostasis was excellent, and at this point the patient was allowed to awaken and transferred to the recovery room in stable condition.All instruments and sponge counts correct times two, and foley catheter was draining blue-tinged urine.As reported by the patient's attorney, the patient experienced an unknown injury.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 15312068
• MDR Text Key: 298801748
• Report Number: 3005099803-2022-04591
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

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 Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female