BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPULSE GUIDE CATHETER

    MDR report key: 3981080 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04832
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RETURNED PRODUCT CONSISTED OF AN IMPULSE CATHETER INSIDE A SEALED INNER PACKAGING POUCH. VISUAL INSPECTION OF THE PACKAGING REVEALED SMALL BROWN FLAKES WITHIN THE PACKAGING. THE DEVICE WAS SENT TO THE BSC MATERIAL TESTING ANALYSIS & CHARACTERIZATION ((B)(4)) LAB FOR FURTHER TESTING, WHICH IDENTIFIED THE BROWN SUBSTANCE AS PROTEIN COMMONLY ASSOCIATED WITH HUMAN FINGER CELLS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE HAS BEEN DETERMINED TO BE RELATED TO A SUPPLIER MANUFACTURING ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKING AND DEVICE HAD FOREIGN MATTER. UPON UNPACKING A IMPULSE GUIDE CATHETER, IT WAS NOTED THAT THE INSIDE OF THE PACKAGING AND ON THE HUB WINGS THERE APPEARED TO BE DIRT OR DUST. THERE WAS NO PATIENT INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKING AND DEVICE HAD FOREIGN MATTER. UPON UNPACKING A IMPULSE GUIDE CATHETER IT WAS NOTED THAT THE INSIDE OF THE PACKAGING AND ON THE HUB WINGS THERE APPEARED TO BE DIRT OR DUST. THERE WAS NO PATIENT INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456944 IMPULSE GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE H74916391402 0050798089

    Patients

    Seq Age Sex Outcome Treatment
    1