BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC EMERGE

    MDR report key: 9385136 · Received November 27, 2019

    Report

    Report Number
    2134265-2019-14552
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 15, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR. : RETURNED PRODUCT CONSISTED OF A NC EMERGE CATHETER. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE. MICROSCOPIC INSPECTION REVEALED A PINHOLE IN THE BALLOON MATERIAL 2MM FROM PROXIMAL MARKERBAND. THERE WAS NO DAMAGE TO THE MARKERBANDS. THE REPORTED BALLOON BURST WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE DEVICE WAS TRIED TO USE AGAIN IN ANOTHER AREA AFTER USING IN KBT, PRESSURE WAS NOT APPLIED; HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00MM X 8MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE DEVICE WAS TRIED TO USE AGAIN IN ANOTHER AREA AFTER USING IN KBT, PRESSURE WAS NOT APPLIED; HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179110 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7311 0022908276

    Patients

    Seq Age Sex Outcome Treatment
    1