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); Perforation (2001); Hematuria (2558)

Event Date 11/22/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx single incision sling (sis) system was implanted during a procedure performed on (b)(6) 2016.On (b)(6) 2017, the patient had erosion of vaginal sling into the bladder, and she underwent removal of mid-urethral sling and cystoscopy with foreign body removal.The patient returned with gross hematuria and was found to have one of the anchoring darts of her sling protruding into the bladder.The patient elected to proceed with the removal of her sling as well as the bladder foreign body.During the procedure, one of the patient's slings became palpable on the right lateral aspect, and this was dissected free beneath the urethra to the left, and the sling was able to be removed.Cystoscopy was performed and the foreign body was still visible within the bladder.Subsequent further dissection was performed and the second sling became evident.This was the miniarc sling.Subsequent dissection was performed and the solyx sling was then identified.It was dissected up into the bladder; however, upon removal, the associated dart was not attached.Cystoscopy was once again repeated and again this was still present.Using the 25-french cystoscope and the stone crushing forceps with summer maneuvers, the anchor sling was able to be grasped and removed in its entirety.Hemostasis was obtained with the bugbee electrode.At the completion of the procedure, bilateral ureteral orifices showed clear efflux and the bladder was intact.The catheter was replaced.The anterior wall was irrigated and closed with a running 2-0 vicryl suture.A vaginal pack was placed.All sponge and instrument counts were correct x2.The patient tolerated the procedure well and was subsequently awoken and taken to the recovery room in stable condition.

Manufacturer Narrative

There was no information available regarding the event date.Therefore, it was approximated to (b)(6) 2016, the implant date has been selected.This event was reported by the patient's legal representation.The implant physician is: (b)(6).The revision physician is: (b)(6).(b)(4).

• 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: 15459054
• MDR Text Key: 300299395
• Report Number: 3005099803-2022-05347
• 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: 07/13/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00003075
• 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: 07/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female