BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 3030154 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01876
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Removal / Correction Number
    90803893FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE FOR THIS COMPLAINT IS SUPPLIER DESIGN. INVESTIGATION OF THE ISSUE FOUND THAT THE VENDOR PROCESS FOR HUB TO CANNULA TRANSITION IS NOT OPTIMIZED TO PRODUCE THE INSERTION TOOL PART. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE WIRE COULD NOT BE INSERTED INTO THE TOOL. THE PT2 LS GUIDE WIRE COULD NOT BE INSERTED THROUGH THE ADVANTAGE INSERTION TOOL. THE PROCEDURE WAS COMPLETED WITH NON-BSC INSERTION TOOL. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134125 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: PT2 LS