BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING

    MDR report key: 10088753 · Received May 26, 2020

    Report

    Report Number
    2134265-2020-06927
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 26, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729757290
    PMA / PMN Number
    K141150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: PATIENT WAS OVER 18 YEARS OLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7X120X130 ELUVIA SELF EXPANDING DRUG ELUTING STENT WAS SELECTED FOR ENDOVASCULAR TREATMENT (EVT) IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A JUPITER FC WIRE WAS ATTEMPTED TO BE USED TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) HOWEVER, THE TIP BECAME KINKED. A NEW WIRE WAS PLACED AND THE CALCIFIED LESION WAS CROSSED. PREDILATION WAS PERFORMED AND A 6X120 ELUVIA DEVICE WAS SUCCESSFULLY PLACED. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE COMPLAINT DEVICE, THE THUMBWHEEL BECAME HARD AND RESISTANCE WAS FELT. THE STENT WAS SLIGHTLY DEPLOYED BUT DUE TO THE RESISTANCE, IT WAS RETRACTED INTO THE SHEATH AND REMOVED FROM THE PATIENT'S BODY. THE PHYSICIAN SUSPECTED A KINK IN THE SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO ADDITIONAL DEVICES OF THE SAME SIZE, FOR A TOTAL OF THREE PLACED STENTS. A STERLING MR, 6.0X40, 135CM BALLOON CATHETER WAS SELECTED FOR POST DILATION AFTER STENTS WERE IMPLANTED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). UPON THE FIRST ATTEMPT AT INFLATING TO THE SPECIFIED PRESSURE, THE BALLOON RUPTURED BETWEEN 6 AND 10 ATMOSPHERES. ANOTHER STERLING DEVICE WAS SELECTED TO COMPLETE THE POST DILATION SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552319 STERLING CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION 24690 0024218924 08714729757290

    Patients

    Seq Age Sex Outcome Treatment
    1 ELUVIA 6X120| ELUVIA 7X120| ELUVIA 7X120| JUPITERFC