BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 3010393 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01981
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Removal / Correction Number
    90803893FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INSERTION TOOL WAS VISUALLY INSPECTED AND IT WAS CONFIRMED AS A DEFECTIVE UNIT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNSPECIFIED TREATMENT PROCEDURE, INSERTION DIFFICULTIES OCCURRED. THE PHYSICIAN COMPLAINED ABOUT DIFFICULTY INSERTING AN UNSPECIFIED GUIDE WIRE THROUGH THE INSERTION TOOL INCLUDED WITH THE ADVANTAGE BALLOON CATHETER INFLATION DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNSPECIFIED TREATMENT PROCEDURE, INSERTION DIFFICULTIES OCCURRED. THE PHYSICIAN COMPLAINED ABOUT DIFFICULTY INSERTING AN UNSPECIFIED GUIDE WIRE THROUGH THE INSERTION TOOL INCLUDED WITH THE ADVANTAGE BALLOON CATHETER INFLATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113944 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011

    Patients

    Seq Age Sex Outcome Treatment
    1