BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 3894097 · Received June 20, 2014

    Report

    Report Number
    1820334-2014-00252
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COOK, INC.
    Product Code
    LIT
    PMA / PMN Number
    K132020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING A THROMBECTOMY FISTULOGRAM ON A (B)(6) MALE PATIENT, HAND INFLATION WAS USED TO INFLATE ALL OF THE BALLOONS IN THIS PROCEDURE. THE FIRST BALLOON WENT THROUGH THE SHEATH ONE TIME AND WAS USED SUCCESSFULLY ONCE. THEY ATTEMPTED TO USE THE FIRST BALLOON AGAIN AND IT WOULD NOT REENTER THE SHEATH. THEY ATTEMPTED TO REWRAP THE BALLOON BUT IT WOULD NOT GO INTO THE SHEATH. THEY THEN OPENED A SECOND BALLOON. THE SECOND BALLOON WENT THROUGH THE SHEATH ONE TIME AND WAS USED SUCCESSFULLY ONCE. THEY ATTEMPTED TO USE THE SECOND BALLOON AGAIN AND IT WOULD NOT REENTER THE SHEATH. THEY ATTEMPTED TO REWRAP THE BALLOON BUT IT WOULD NOT GO INTO THE SHEATH. THEY THEN OPENED A THIRD BALLOON. THIS BALLOON RUPTURED DURING ITS SECOND INFLATION. BALLOON FRAGMENTS REMAINED INSIDE THE PATIENT'S RIGHT AXILLARY VEIN. A STENT WAS USED TO TACK THE BALLOON FRAGMENTS TO THE VESSEL WALL SO THAT THE FRAGMENTS DON'T CAUSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364075 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT COOK, INC. NA 4783386

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention