BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPULSE GUIDE CATHETERS

    MDR report key: 1895117 · Received November 10, 2010

    Report

    Report Number
    2134265-2010-04869
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED TREATMENT PROCEDURE, FOREIGN MATERIAL WAS IDENTIFIED. UPON OPENING THE PACKAGE OF A 5F IMPULSE GUIDE CATHETER, "A BUG FLEW OUT OF IT". THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPULSE GUIDE CATHETER. THERE WERE NO ISSUES NOTED WITH THE SEAL OF THE PACKAGE OR THE CONTENTS OF THE POUCH. AS THERE WAS NO PATIENT CONTACT, NO PATIENT COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPULSE GUIDE CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H749163913011

    Patients

    Seq Age Sex Outcome Treatment
    1