BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE BALLOON DILATATION CATHETER

    MDR report key: 2150263 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02067
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PACKAGING WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS REPORTED FOR THE SAME LOT. THE (B)(6) 2008 15-MONTH CRE BALLOONS 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

    NOTE: DATE OF THE EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2008 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS PLANNED FOR USE; HOWEVER, THE COMPLAINANT REALIZED THE DEVICE WAS MISSING AFTER OPENING THE PACKAGE. THERE WAS NO ADDITIONAL INFORMATION ASCERTAINED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE FIXED WIRE BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORPORATION M00558380 0011416434

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK