BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2850394 · Received November 29, 2012

    Report

    Report Number
    2134265-2012-07676
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 1, 2012
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. 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 A UNSPECIFIED TREATMENT PROCEDURE, INSERTION DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. DIFFICULTY WAS NOTED WHILE ATTEMPTING TO INSERT AN UNSPECIFIED GUIDE WIRE THROUGH THE INSERTION TOOL INCLUDED WITH THE ADVANTAGE BALLOON CATHETER INFLATION DEVICE AND THE GUIDE WIRE HAD TO BE BACKLOADED THROUGH THE INSERTION TOOL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1