BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO

    MDR report key: 6770478 · Received August 7, 2017

    Report

    Report Number
    6770478
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    June 27, 2017
    Report Date
    July 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGERY WAS AN ANTERIOR REPAIR SACROSPINOUS LIGAMENT SUSPENSION TO THE LEFT SACROSPINOUS LIGAMENT USING A MICHIGAN FOR WALL TECHNIQUE. AN INCISION WAS MADE IN THE TRIANGLE FASHION OVER THE BLADDER. THE UTEROSACRAL DIMPLES WERE USED AS A LATERAL MARKERS. THE EXCESS VAGINAL TISSUE WAS REMOVED. THE PUBOVESICAL AND PUBOURETHRAL FASCIA WAS HARVESTED. WE PLICATED THE UTEROVESICAL LIGAMENTS TOGETHER IN THE MID LINE TO REDUCE THE CYSTOCELE. WE IDENTIFIED THE UTEROSACRAL LIGAMENTS AND ATTACHED THE PUBOVESICAL FASCIA TO THOSE WITH A 0 VICRYL. WE MADE A MID LINE INCISION IN THE POSTERIOR VAGINA. WE DISSECTED LATERAL TO THE RECTUM DOWN TO THE SACROSPINOUS LIGAMENT. WE DID THIS ON THE LEFT SIDE. ON THE RIGHT SIDE WE HAD SOME DIFFICULTY WITH EXPOSURE. WE DECIDED TO PLACE SUTURES IN THE LEFT SACROSPINOUS LIGAMENT AND ATTACHED THEM TO THE VAGINAL APEX. WE OPENED THE PERITONEAL CAVITY AND ATTACHED THE MONODEK SUTURE TO THE UTEROSACRAL LIGAMENTS ON BOTH SIDES. THESE MONODEK SUTURES WERE THEN PASSED THROUGH THE SACROSPINOUS LIGAMENT ON THE LEFT SIDE. WHEN WE PLACED A THIRD SUTURE THROUGH WITH A CAPIO NEEDLE PASSER. THE END OF THE CAPIO BROKE AND APPROXIMATELY 4 MM OF THE CAPIO NEEDLE AND THE BULLET END OF THE MONODEK WERE LEFT IN THE SACROSPINOUS LIGAMENT. IT WOULD BE IMPOSSIBLE TO FIND THE SMALL PIECES AS THE SACROSPINOUS LIGAMENT IS DEEP IN THE PELVIS AND THE LIGAMENT ITSELF IS MUSCLE AND TENDON WHICH IS DIFFICULT TO EXPLORE. WE THEN CLOSED THE VAGINAL PERITONEUM AND THEN WE BEGAN TYING DOWN THE VAGINAL WALL UTILIZING THE MONODEK SUTURES. IT WAS ALSO REPORTED THAT THE RESIDENT THAT WAS HOLDING THE DEVICE WAS TOLD THAT THE PLACEMENT OF SUTURE NEEDED TO COUNT. RESIDENT THEN PUSHED THE PLUNGER AND NEEDED TO REALLY EXERT MORE PRESSURE TO GET THE DEVICE TO DEPLOY, BUT INSTEAD IT BROKE OFF 2 MM OF THE BULLET AND 1 CM OF THE METAL RING. DISCLOSURE WAS DONE AND THE PHYSICIAN DECIDED THAT THE REMNANTS WERE SO SMALL IT WOULD BE IMPOSSIBLE TO RETRIEVE, SO NO ATTEMPT WAS MAD TO FIND OR REMOVE THE FOREIGN BODIES THAT WERE EMBEDDED IN THE SACROSPINOUS LIGAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551369 CAPIO HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION M0068311250 20225741

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CAPIO SUTURE CAPUTURING DEVICE WAS BEING USED TO H| NO OTHER THERAPIES