BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5353286 · Received January 8, 2016

    Report

    Report Number
    3011770902-2016-00017
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 30, 2015
    Report Date
    January 4, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVALUATION INFO. THIS SPARC PRESENTED WITH TWO NEEDLES WITH CONNECTORS ATTACHED. ONE NEEDLE POSSESSED A LENGTH OF SHEATH/SLING THAT HAD BEEN CUT FROM THE REMAINING SHEATH/IMPLANT ASSEMBLY. THE OTHER NEEDLE POSSESSED THE REMAINING PORTION OF THE SHEATH AND IMPLANT WITH THE EXCEPTION OF ~5INCH LENGTH OF SHEATH WHICH HAD BEEN CUT OFF AND WAS LOOSE. THE MESH WAS ELONGATED AND NECKED ALONG MUCH OF ITS LENGTH AND WAS BLOODY. THE SLING WAS IN A SINGLE PIECE AND WAS NOT TORN. A PORTION OF THE SLING WAS NOT COVERED BY SHEATH WHILE A PORTION WAS COVERED. THE SUTURE WAS BROKEN WHILE STILL BEING INCORPORATED WITHIN THE MESH, INSIDE THE SHEATH. THE TWO SLING PIECES HAD BEEN SEPARATED FROM ONE ANOTHER AS THERE WAS NO OVERLAPPING SEQUENCE. ON BOTH ENDS OF THE SEPARATED SHEATH WHERE THEY ORIGINALLY OVERLAPPED THERE WAS A ~1" SLIT DOWN THE MIDDLE OF THE SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPARC IMPLANT, THE PHYSICIAN COULD NOT GET THE PLASTIC SHEATH AROUND THE MESH TO SEPARATE. WHILE TRYING TO REMOVE THE PLASTIC, THE SLING TORE. A NEW SLING WAS USED TO COMPLETE THE PROCEDURE; NO PATIENT COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12006 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1