BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS KIT

    MDR report key: 5953619 · Received September 15, 2016

    Report

    Report Number
    2125050-2016-00221
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    July 21, 2016
    Report Date
    November 4, 2016
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ALTIS SLING AND TWO INTRODUCERS WERE RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED COMPONENTS WAS NOT PERFORMED, AS IT WAS REPORTED THAT USE ERROR OF THE DEVICE WAS THE ROOT CAUSE OF THE DEVICE FAILURE. IT WAS NOTED THAT THE STATIC ANCHOR WAS CUT AWAY FROM THE SLING, INDICATING IT WAS THE ANCHOR THAT WAS INCORRECTLY PLACED INTO THE VAGINAL WALL. THE INTRODUCER IS DESIGNED TO DELIVER THE ANCHOR TO THE DESIRED LOCATION IN THE OBTURATOR INTERNUS MUSCLE, HOWEVER IF THE SURGICAL STEPS LAID OUT IN THE IFU ARE NOT FOLLOWED, THE ANCHOR CAN BE INCORRECTLY PLACED. IN THIS CASE, EITHER THE CEPHALAD DRIFT, PRIOR TO TURNING THE INTRODUCER, WAS NOT PERFORMED, OR THE INTRODUCER WAS NOT HELD PARALLEL TO THE DESCENDING RAMUS AS INSTRUCTED IN THE IFU, RESULTING IN THE ANCHOR BEING IMPLANTED IN THE VAGINAL WALL INSTEAD OF THE OBTURATOR INTERNUS. IT CANNOT BE CONCLUSIVELY DETERMINED EXACTLY WHICH STEP WAS NOT FOLLOWED BASED ON THE PROVIDED INFORMATION, HOWEVER BOTH ARE INSTANCES OF USE ERROR (IATROGENIC USE) SINCE THE IFU STEPS WERE NOT FOLLOWED. IT WAS CONCLUDED THAT THIS USE ERROR WAS THE ROOT CAUSE OF THE REPORTED EVENT. THIS COMPLAINT WAS FORWARDED TO THE CONTRACT MANUFACTURER (CM) FOR REVIEW. THE CM REVIEWED THE MANUFACTURING RECORDS FOR LOT 4944763 TO VERIFY THAT THERE WERE NO DISCREPANCIES AND CONFIRMED THAT ALL DEVICES FROM THE LOT MET SPECIFICATIONS. THE FULL CM RESPONSE AND LOT CERTIFICATION RECORD IS ATTACHED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A LACK OF GUIDE FOR INTRODUCING THE MESH SO THERE WAS PERFORATION OF THE VAGINAL WALL. IT WAS IMPOSSIBLE TO GO BACK AND SECTION THE ANCHOR. THERE WERE NO OBSERVED CLINICAL CONSEQUENCES. IT WAS USER ERROR AND THERE HAD NEVER BEEN A GUIDE WITH ALTIS. THE UROLOGIST TOOK THE VAGINAL CUL-DE-SAC AND PERFORATED THE VAGINAL WALL. HE SEWED THE WALL AND IMPLANTED ANOTHER ALTIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606408 ALTIS KIT SURGICAL MESH PAH COLOPLAST A/S 5196501022 4944763

    Patients

    Seq Age Sex Outcome Treatment
    1 Other