BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2992630 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01241
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 8, 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
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS MFR ID # 2134265-2013-01239, 2134265-2013-01240, 2134265-2013-01242. IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE WIRE COULD NOT BE INSERTED INTO THE TOOL. THE GUIDE WIRE COULD NOT GO THROUGH THE ADVANTAGE INSERTION TOOL. FOUR DIFFERENT INSERTION TOOLS WERE USED IN THE PROCEDURE. 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
    96950 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011

    Patients

    Seq Age Sex Outcome Treatment
    1