BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTV TRANSVAGINAL SLING SYSTEM

    MDR report key: 10462616 · Received August 27, 2020

    Report

    Report Number
    3013859837-2020-00004
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 26, 2020
    Manufacturer
    UROCURE, LLC
    Product Code
    OTN
    PMA / PMN Number
    K183134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER DISCUSSION WITH DR. (B)(6) REGARDING THE THREE PATIENTS WITH MESH EXPOSURES, IT WAS DETERMINED THAT THE ROOT CAUSE FOR THE EXPOSURES ARE DUE TO THE FOLLOWING: THE INCISION MADE BY THE SURGEON IN ORDER TO PASS THE SUSPENSION NEEDLE HAS BEEN MINIMIZED BY HIS CHOICE OF DISSECTION TECHNIQUE. HE ALSO EMPLOYS MINIMAL DISSECTION OF THE TUNNEL AND HAS RELIED IN THE PAST ON THE SUSPENSION NEEDLE AND SLING-SHEATH TO DILATE THE TRACT. THE SMALL SIZE OF THE TRACT MAY BE CONTRIBUTING TO THE ROLLING OF THE SOFT-SHEATH WITH ARCTV AND WHEN THE SHEATH IS REMOVED, THE EDGES OF THE MESH ROLLING/CURLING WITHIN THE DISSECTION TUNNEL AND THE INCISION SITE. THE CURLING BENEATH THE INCISION MAY INCREASE THE RISK OF EXPOSURE. DR. (B)(6) MENTIONED THAT HE IS NOW MAKING THE INCISION TUNNEL LARGER BY PASSING HIS FINGER BEHIND THE SHEATH AND THE TROCAR INTO THE DISSECTION TUNNEL TO EXPAND THE INCISION AND TUNNEL. DISCUSSION WITH DR. (B)(6) CMO/UROCURE AND OTHER SURGEONS WHO PERFORM THIS PROCEDURE CONFIRMED THAT A LARGER INCISION AND DISSECTION TUNNEL FACILITATES IN PASSING THE SOFT-SLING SHEATH WITH THE MESH AND AFTER SHEATH REMOVAL ALLOWS THE MESH TO BE SITUATED FLAT BELOW THE INCISION AND WITHIN THE DISSECTION TUNNEL. THE INCISIONS THEY MADE IN RECENT SURGERIES WERE MEASURED AND THEY RANGED FROM 1.2-1.5CM. WHICH ARE LARGER THAN THE SLING WIDTH. THE INCISION WITH MINIMAL DISSECTION IS OFTEN LESS THAN 1CM AS IS THE TUNNEL MADE BY THE SUSPENSION NEEDLE AND SOFT-SHEATH. OTHER CONTRIBUTING FACTORS COULD BE DUE TO THE RISK LEVEL OF THE PATIENT. PATIENT IS CONSIDERED HIGH RISK DUE TO ADDISONS DISEASE / STEROIDS AND A PRIOR MESH PLACEMENT THAT REQUIRED A REVISION/REMOVAL.

    Description of Event or Problem · 1

    EXTRUDED MESH IN MIDLINE SUBURETHRAL INCISION. INITIAL SLING PLACEMENT (B)(6) 2020. SLING REVISION PERFORMED ON (B)(6) 2020 TO EXCISE THE EXPOSED MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926312 ARCTV TRANSVAGINAL SLING SYSTEM URINARY SLING OTN UROCURE, LLC A-TV-1001

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention