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 Hypersensitivity/Allergic reaction (1907); Laceration(s) (1946); Rash (2033); Scar Tissue (2060)

Event Date 11/15/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted during a solyx mini sling with cystoscopy and diagnostic laparoscopy procedures performed on (b)(6) 2018 to treat a patient with right lower quadrant pain and stress urinary incontinence.On (b)(6) 2018, the patient presented to the emergency department (er) with a systemic rash and the physicians could not find a source for the rash.The physicians suspected allergic reaction to the solyx mini sling implanted about three weeks ago which may be causing the rash.The patient opted to have the mesh implant removed and an excision of the solyx mini sling was then performed.The patient was taken to the operating room, where general anesthesia was obtained.The patient was then prepped and draped in the normal sterile fashion in the dorsal lithotomy position.A weighted speculum was placed in the vagina.The old suture was removed with metzenbaum scissors.The sling was found to be a little bit above this area and was scarred into place underneath the urethra.This was grasped and then the physician dissected it using the physician's finger to the obturator canal and pulled on the sling.The sling was removed intact.The physician did see the end of the sling.This was done on both sides and this was removed and sent to pathology.Some of the vaginal mucosa did tear since it was a fresh surgery, so some of the old tissue was excised and then the vaginal mucosa was closed with a #2-0 vicryl in a running fashion.Hemostasis was noted and the sponge, instrument, and needle counts were correct.The patient was taken to recovery room in stable condition.

Manufacturer Narrative

The complainant was unable to provide the upn and lot number of the suspect device.The provided upn is a representation of the solyx sis system implanted.Therefore, the manufacture and expiration dates are unknown.Initial reporter: this event was reported by the patient's legal representation.The implant and explant surgeon 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15503259
• MDR Text Key: 300776591
• Report Number: 3005099803-2022-05416
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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
• Date Manufacturer Received: 09/08/2022
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female