BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE BALLOON DILATATION CATHETER

    MDR report key: 2150281 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02077
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PACKAGING WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A LOT HISTORY SEARCH REVEALED NO SIMILAR COMPLAINTS AGAINST THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THE (B)(6) 2008, 15-MONTH CRE BALLOON FIXED WIRE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS PLANNED FOR USE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, THERE WAS NO PRODUCT INSIDE THE BOX WHEN OPENED. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE FIXED WIRE BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORPORATION M00558360 0008765894

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK