BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTV TRANSVAGINAL SLING SYSTEM

    MDR report key: 10462159 · Received August 27, 2020

    Report

    Report Number
    3013859837-2020-00001
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    May 5, 2020
    Report Date
    August 25, 2020
    Manufacturer
    UROCURE, LLC
    Product Code
    OTN
    PMA / PMN Number
    K183134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER DISCUSSION WITH OTHER PHYSICIANS THAT PERFORM MID-URETHRAL SLING SURGERIES, IT WAS DETERMINED THAT THE PROCEDURE MOST LIKELY CONTRIBUTED TO THE SLING TWISTING FOR THE FOLLOWING REASONS: THE INCISION MADE BY THE SURGEON IN ORDER TO PASS THE SUSPENSION NEEDLE HAS LIKELY BEEN MINIMIZED BY HER CHOICE OF DISSECTION TECHNIQUE. SHE ALSO LIKELY EMPLOYS MINIMAL DISSECTION OF THE TUNNEL AND RELIES 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. 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. DR (B)(6) REMOVED ARCTV SLING DURING THE SAME SURGERY BECAUSE SHE COULDN'T GET IT TO LIE FLAT AND REPLACED WITH A DIFFERENT SLING.

    Description of Event or Problem · 1

    DURING A MID-URETHRAL SLING SURGERY, THE MESH ROLLED LONGITUDINALLY MULTIPLE TIMES. THE DOCTOR REMOVED THE SLING DURING THE SAME SURGERY AND REPLACED IT WITH A DIFFERENT SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928156 ARCTV TRANSVAGINAL SLING SYSTEM URINARY SLING OTN UROCURE, LLC A-TV-1001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention