BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 5675417 · Received May 24, 2016

    Report

    Report Number
    3011770902-2016-00263
    Event Type
    Malfunction
    Date Received
    May 24, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 19, 2016
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. ANALYSIS: SPARC NEEDLES WERE RETURNED WITH DILATORS ATTACHED INCLUDING THE TAIL ENDS OF THE SHEATH AND MESH AS WOULD BE EXPECTED DURING A NORMAL PROCEDURE. THE IMPLANTABLE PORTION OF THE MESH WAS RETURNED IN THREE PIECES. ONE SECTION WAS CUT ON BOTH ENDS. THE OTHER SECTIONS WERE CUT ON ONE END AND TORN ON THE OTHER. THE MESH IS ALSO SLIGHTLY STRETCHED IN 2 AREAS AWAY FROM THE TEAR. THE SHEATH SECTIONS COVERING THE MESH WERE NOT RETURNED. UNABLE TO DETERMINE THE CAUSE FOR THE TEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF A SPARC SLING, THE PHYSICIAN EXPERIENCED DIFFICULTY PULLING THE SHEATH OUT AND WAS ONLY ABLE TO DO SO FROM ONE SIDE AND WHEN HE DID, THE SLING WAS SHREDDED. THE PHYSICIAN THEN REMOVED THE SLING AND IMPLANTED A NEW SLING. NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332187 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention