FDA Adverse Event Malfunction Summary report: N

SOLYX

MDR report key: 3113332 · Received May 10, 2013

Report

Report Number
3113332
Event Type
Malfunction
Date Received
May 10, 2013
Date of Event
April 15, 2013
Report Date
May 10, 2013
Manufacturer
BOSTON SCIENTIFIC
Product Code
PAH
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

PATIENT HAD A MIDURETHRAL SLING PERFORMED. SHE HAS BEEN HAVING A PINCHING AND UNCOMFORTABLE SENSATION IN HER VAGINA SINCE THAT TIME AND HAS BEEN VERY BOTHERED BY THIS. SURGEON DISCUSSED THE PROS AND CONS OF REMOVING THE SLING AT LENGTH, AND SHE UNDERSTANDS THAT REMOVING THE SLING WILL LEAD TO RECURRENCE OF HER INCONTINENCE, MAY NOT IMPROVE HER PAIN, AND COULD POTENTIALLY INJURE SURROUNDING ORGANS; HOWEVER, SHE WOULD STILL LIKE TO PROCEED. SHE ALSO DID HAVE SOME BLOOD IN HER URINE AND HAD SYMPTOMS SUGGESTIVE OF INTERSTITIAL CYSTITIS, SO A CT UROGRAM WAS PERFORMED WHICH WAS NEGATIVE AND A CYSTOSCOPY WAS PERFORMED DURING THE PROCEDURE. SURGEONS WERE ABLE TO GET AROUND THE MESH LATERAL TO THE URETHRA AND DISSECT AROUND IT, DIVIDED IN THE MIDDLE, AND THEN EACH ARM WAS DISSECTED LATERALLY ALL THE WAY TO THE OBTURATOR FORAMEN, BROUGHT UP BILATERALLY WITHOUT ANY DIFFICULTY. THE ANCHORS WERE NOT ABLE TO REMOVE FROM THE OBTURATOR FORAMEN; HOWEVER, SURGEONS WERE ABLE TO REMOVE THE ENTIRETY OF THE MESH ON BOTH SIDES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXCISION OF MIDURETHRAL MESH SLING, AS WELL AS CYSTOSCOPY AND HYDRODISTENTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
205006 SOLYX MESH, SURGICAL, POLYMERIC PAH BOSTON SCIENTIFIC SOLYX UNK

Patients

Seq Age Sex Outcome Treatment
1 47 YR