BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTRA MPH-45

    MDR report key: 7246811 · Received February 7, 2018

    Report

    Report Number
    1028232-2018-00413
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    November 22, 2017
    Report Date
    February 1, 2018
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DQY
    PMA / PMN Number
    K110461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    NO MANUFACTURE DATE CAN BE PROVIDED. UPON RECEIPT, THE RETURNED SELECTRA MPH WAS THOROUGHLY ANALYSED. DURING THE VISUAL INSPECTION, THE SELECTRA CATHETER WAS FOUND SEVERELY STRETCHED BETWEEN 28.5 CM AND 42.4 CM DISTAL TO THE HANDLE PIECE. THESE DAMAGES WERE CONSISTENT WITH THE OBSERVATION REPORTED IN THE COMPLAINT TEXT. THE ABOVE MENTIONED FINDINGS SUGGEST AN UNEXPECTED MATERIAL FATIGUE IN THE DISTAL THIRD OF THE CATHETER. IN SPITE OF A THOROUGH ANALYSIS, NO DEFINITE ROOT CAUSES FOR THIS MATERIAL BEHAVIOR COULD BE DETERMINED. THE RE-INVESTIGATION OF THE MANUFACTURING PROCESS FOR THIS DEVICE SHOWED THAT THE PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY WITHOUT ANY INCONSISTENCIES DURING THE ASSEMBLY.

    Description of Event or Problem · 1

    OUS MDR - DURING THE PROCEDURE A DAMAGE OF THE OUTER CATHETER SURFACE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92031 SELECTRA MPH-45 CATHETER DQY BIOTRONIK SE & CO. KG 375533

    Patients

    Seq Age Sex Outcome Treatment
    1