BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2862033 · Received December 7, 2012

    Report

    Report Number
    2134265-2012-07701
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Removal / Correction Number
    90803893FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    (B)(4).IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, INSERTION DIFFICULTIES OCCURRED. MEDICAL DEVICE CUSTOMER NOTIFICATION - IMMEDIATE ACTION REQUIRED: BOSTON SCIENTIFIC, ENCORE 26 ADVANTAGE KIT, INSERTION TOOL. "BOSTON SCIENTIFIC HAS DISCOVERED THAT USERS OF THE ENCORE 26 ADVANTAGE KITS WHICH WERE MANUFACTURED BETWEEN 08/03/2012 AND 09/18/2012 MAY EXPERIENCE DIFFICULTY IN PASSING GUIDEWIRES THROUGH THE INSERTION TOOL WHICH IS INCLUDED WITH ENCORE 26 ADVANTAGE KITS. THE DIFFICULTY TO PASS GUIDEWIRES, ESPECIALLY J TIPPED GUIDEWIRES, THROUGH THE INSERTION TOOL IS CAUSED BY A JACK OF SMOOTHNESS WITHIN THE HUB/HYPO TUBE TRANSITION IN SOME DEVICES. THIS ISSUE MAY LEAD TO A CLINICALLY INSIGNIFICANT PROLONGATION OF THE PROCEDURE UPON ATTEMPT TO INSERT A GUIDEWIRE INTO THE INSERTION TOOL BUT IS NOT EXPECTED TO CAUSE INCREASED RISK OF INJURY." HAS PROLONGED PROCEDURE, HAS CREATED THE NEED TO LOAD WIRE FROM THE BACK END, HAS DAMAGED WIRE AND MORE EQUIPMENT HAD TO BE ADDED TO PROCEDURE AND CREATING MORE COSTS. CREATING FRUSTRATION FOR PHYSICIANS, AND ADDITIONAL INSERTION TOOLS AND ESSENTIALS KITS TO BE ADDED TO PROCEDURE.

    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