BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON

    MDR report key: 8906271 · Received August 19, 2019

    Report

    Report Number
    2134265-2019-09857
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5 PREMARKET UPDATED: P950020

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT 6 ATM FOR 15 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION AREA WAS LOCATED IN A SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA), AND THE PATIENT'S CONDITION WAS GOOD AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00MM/1.5CM/140CM SMALL PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT 6 ATM FOR 15 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701290 SMALL PERIPHERAL CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC CORPORATION 24658 0023507958

    Patients

    Seq Age Sex Outcome Treatment
    1