BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 3021483 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01972
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: PRODUCT ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED AS THE UNIT WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE 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#: 2134265-2013-01971. IT WAS REPORTED THAT DURING A CORONARY PROCEDURE INSERTION DIFFICULTIES OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. THE PHYSICIAN WAS UNABLE TO INSERT AN UNSPECIFIED GUIDE WIRE THROUGH THE INSERTION TOOL INCLUDED WITH THE ADVANTAGE BALLOON CATHETER INFLATION DEVICE. A SECOND ADVANTAGE BALLOON CATHETER INFLATION DEVICE WAS USED AND AGAIN THE PHYSICIAN ENCOUNTERED DIFFICULTIES WHILE INSERTING THE GUIDE WIRE. A THIRD ADVANTAGE BALLOON CATHETER INFLATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123115 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011 0015756325

    Patients

    Seq Age Sex Outcome Treatment
    1