BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA

    MDR report key: 4927669 · Received July 17, 2015

    Report

    Report Number
    2025182-2015-00004
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 17, 2015
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K800563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU), THE EVENT OF LEAKAGE IS A DOCUMENTATION/KNOWN COMPLICATION: "INTRACTABLE LEAKAGE AROUND THE PROSTHESIS, REQUIRING ADJUSTMENT OR RE-FITTING OF THE PROSTHESIS, OR OTHER SURGICAL/PROSTHETIC OF MEDICAL MANAGEMENT OPTIONS." ALSO DOCUMENTED IN THE IFU: "ACCIDENTAL ASPIRATION OF THE PROSTHESIS INTO THE AIRWAY, WHICH MAY REQUIRE REMOVAL BY A PHYSICIAN."

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA IN THE OPERATING ROOM, THE PHYSICIAN WAS PLACING A FISTULA DEVICE, CATALOG NUMBER FM1004, FROM AN UNKNOWN LOT NUMBER. THE CATHETER WAS PLACED WITH NO DIFFICULTIES, HOWEVER THE LOCKING LOOP "DIDN'T LOCK EASILY ON THE DEVICE DUE TO SALIVA. THE PHYSICIAN USED A PIECE OF SILK TO TIE THE BEADED STEM TO THE CATHETER. THE DEVICE WAS PLACED AND THE PATIENT WAS THEN TAKEN TO POST-OP CARE WHERE THEY WERE TESTED FOR LEAKAGE. THEY FOUND LEAKAGE OF THE DEVICE, AND WENT IN TO TIGHTEN THE DEVICE USING HEMOSTATS. ABOUT 2 TO 3 BEADS IN, THE DEVICE SNAPPED." THE PARTIAL DEVICE IS STILL IN THE PATIENT, WHO REMAINS IN THE HOSPITAL FOR AN UNRELATED REASON. THE NEXT DAY, THE PHYSICIAN USED A BRONCHOSCOPE AND REMOVED THE DEVICE, AND A NEW FISTULA WAS PLACED IN WITHOUT A PROBLEM, NO LEAKAGE. DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464869 BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA FISTULA PROSTHESIS EWL HELIX MEDICAL, LLC FM1004 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention