BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTRA MPH 55

    MDR report key: 7793349 · Received August 17, 2018

    Report

    Report Number
    1028232-2018-02939
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    August 13, 2018
    Report Date
    August 13, 2018
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2018 - WE RECEIVED NEW ANALYSIS INFORMATION. WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE ANALYSIS IS THUS BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS ON THE PROVIDED INFORMATION. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. THE AVAILABLE PHOTO SHOWED A DAMAGED SELECTRA WITH A DETACHED HANDLE PIECE. VISIBLE BLOOD RESIDUALS MAY BE TAKEN AS AN INDICATION THAT THE SELECTRA WAS USED DURING AN IMPLANTATION PROCEDURE. IN SPITE OF THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. AN ANALYSIS OF THE DEVICE WOULD BE NECESSARY FOR A ROOT CAUSE INVESTIGATION. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS SELECTRA WAS USED DURING AN IMPLANT. WHEN THE PHYSICIAN REMOVED THE SELECTRA, IT WAS NOTED THAT PART HAD BROKEN OFF. THE PRODUCT WAS DISCARDED BY THE PHYSICIAN, HOWEVER A PICTURE WAS TAKEN FOR THE COMPLAINT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636294 SELECTRA MPH 55 CATHETER DQY BIOTRONIK SE & CO. KG 375534 09172478

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR