BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2862313 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07746
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 8, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT 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 PERCUTANEOUS ANGIOPLASTY TREATMENT PROCEDURE, INSERTION DIFFICULTIES OCCURRED. DIFFICULTY WAS NOTED WHILE ATTEMPTING TO INSERT A NON-BSC GUIDE WIRE THROUGH THE INSERTION TOOL. A KINK WAS NOTED ON THE NON-BSC GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY CONTINUED WITH ANOTHER ADVANTAGE 26 ENCORE INFLATION DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 GUIDE WIRE: BMW - ABBOTT