BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR DEVICE, 135X40CM

    MDR report key: 13957347 · Received March 30, 2022

    Report

    Report Number
    2134265-2022-03443
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 5, 2022
    Report Date
    May 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006301
    PMA / PMN Number
    K182324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS BY MANUFACTURER: THE DEVICE WAS INSPECTED FOR ANY DAMAGE OR IRREGULARITIES. THE USC WAS NOT RETURNED. THE RETURNED IC HAD BLOOD THROUGHOUT THE DEVICE SHOWING SIGNS OF OBVIOUS USE. THE IC WAS FOUND WITH A SEVERE KINK 1.5CM FROM THE STRAIN RELIEF. A SECOND LESS SEVERE KINK WAS LOCATED 69.7CM FROM THE STRAIN RELIEF; THE OD RING GAGE FAILED AT THIS LOCATION. THE IC SHOWED SOME DAMAGE IN THE FORM OF WAVY WIRES UNDER THE STRAIN RELIEF. A GUIDEWIRE WAS ADVANCED THROUGH THE IC WITH SOME DIFFICULTY AND LOADED INTO A BEND JIG; AN IN-HOUSE USC WAS ATTEMPTED TO BE LOADED INTO THE IC AND WAS UNABLE TO MAKE IT PAST THE FIRST MAJOR KINK AT 1.5CM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE. A 135X40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR A UNILATERAL PULMONARY ARTERY OCCLUSION PROCEDURE. DURING PLACEMENT OF THE EKOSONIC ENDOVASCULAR DEVICE, THE INFUSION CATHETER WOULD NOT TRACK CONTRALATERALLY OVER THE .035 INCH GUIDEWIRE. THE INFUSION CATHETER KEPT GETTING STUCK AND EVENTUALLY KINKED. THE DEVICE BECAME DIFFICULT TO REMOVE, AND AFTER A SHORT PERIOD OF TIME, THE WIRE AND CATHETER WERE ABLE TO BE REMOVED TOGETHER. THE WIRE AND CATHETER WERE ABLE TO BE SEPARATED AFTER REMOVAL FROM THE PATIENT; HOWEVER, A DIFFERENT WIRE AND A DIFFERENT EKOSONIC CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE. A 135X40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR A UNILATERAL PULMONARY ARTERY OCCLUSION PROCEDURE. DURING PLACEMENT OF THE EKOSONIC ENDOVASCULAR DEVICE, THE INFUSION CATHETER WOULD NOT TRACK CONTRALATERALLY OVER THE .035 INCH GUIDEWIRE. THE INFUSION CATHETER KEPT GETTING STUCK AND EVENTUALLY KINKED. THE DEVICE BECAME DIFFICULT TO REMOVE, AND AFTER A SHORT PERIOD OF TIME, THE WIRE AND CATHETER WERE ABLE TO BE REMOVED TOGETHER. THE WIRE AND CATHETER WERE ABLE TO BE SEPARATED AFTER REMOVAL FROM THE PATIENT; HOWEVER, A DIFFERENT WIRE AND A DIFFERENT EKOSONIC CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608857 EKOSONIC ENDOVASCULAR DEVICE, 135X40CM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION 500-56140 0010804352 00858593006301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown