BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTRA MPH-45 GUIDING CATHETER

    MDR report key: 6816544 · Received August 24, 2017

    Report

    Report Number
    MW5071777
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 22, 2017
    Manufacturer
    BIOTRONIK
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SELECTRA MPH-45 BIOTRONIK CATHETER SERIAL #(B)(4), LOT #05167509 WAS LEFT IN PT AFTER AICD PLACEMENT; 9 FRENCH SHEATH AND GUIDING CATHETER PLACE FOR THE CORONARY SINUS AND CONTRAST INJECTION MADE IN CORONARY SINUS .014 WHISPER MS WIRE INSERTED. CORONARY SINUS LEAD INSERTED AND ADVANCED AND TESTED, REPOSITIONED AND TESTED. THE SURGEON WAS PULLING AND CUTTING WITH A SLITTER GUIDING CATHETER AFTER SHEATH WS REMOVED. A 10 CM PIECE FROM GUIDING CATHETER WAS LEFT AND WILL STAY ON THE LEAD. TWO VASCULAR SURGEONS WERE CALLED AND THEIR RECOMMENDATION WAS TO LEAVE THE PIECE OF GUIDING CATHETER IN THE LEAD AND NOT REMOVE IT. THE CATHETER WITH LEAD IN THE SUPERIOR VENA CAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599309 SELECTRA MPH-45 GUIDING CATHETER CATHETER PERCUTANEOUS DQY BIOTRONIK 05167509

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other