BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTRA MPH-45

    MDR report key: 6043628 · Received October 20, 2016

    Report

    Report Number
    1028232-2016-03858
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 21, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DQY
    PMA / PMN Number
    K110461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DATE WAS UNABLE TO BE IDENTIFIED. UPON RECEIPT, THE SELECTRA MPH-45 WAS FOUND TORN INTO TWO PIECES APPROX. 33.5 CM DISTALTO THE HANDLE PIECE WHICH WERE BOTH RETURNED FOR ANALYSIS. THE ANALYSIS OF THE SELECTRA MPH-45 REVEALED A HELICAL CUTTING LINE ALONG THE PROXIMAL CATHETER FRAGMENT. FURTHERMORE THE INSPECTION OF THE SLITTER TOOL SHOWED DEFORMATIONS OF THE LEFT AND THE RIGHT CLAMP. ON BOTH FRAGMENTS MULTIPLE CUTS, KINKS AND OFFSETS WERE VISIBLE. THE MORPHOLOGY OF THESE FINDINGS INDICATES THAT THE SLITTER TOOL DEVIATED FROM THE LONGITUDINAL DIRECTION AND JAMMED, RESULTING IN THE OBSERVED TORN OFF. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS SENSITIVELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND. FOR THIS REASON WE ENCOURAGE CLOSE DIALOGUE BETWEEN CLINICIANS AND OUR PRODUCT EXPERTS IN ORDER TO EXPLORE ALL OPTIONS TO MINIMIZE ANY SUCH OCCURRENCES IN FUTURE.

    Description of Event or Problem · 1

    THIS INTRODUCER WAS USED, BUT THE DOCTOR FELT THE SHEATH SPLIT INAPPROPRIATELY AND HAD TO USE AN IRIS SCISSOR TO CUT IT OFF. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695305 SELECTRA MPH-45 INTRODUCER DQY BIOTRONIK SE & CO. KG 375533

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization