BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANER15 ROTATIONAL THROMBECTOMY DEVICE

    MDR report key: 3565921 · Received November 8, 2013

    Report

    Report Number
    3003862657-2013-00006
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 4, 2013
    Report Date
    November 8, 2013
    Manufacturer
    REX MEDICAL L.P.
    Product Code
    MCW
    PMA / PMN Number
    K091029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT F/U: REVIEW OF CASE SUMMARY PROVIDED BY THE HOSPITAL; NO COMPLAINT SAMPLE RETURNED FOR EVAL; NO CASE IMAGES, VIDEOS, ETC WERE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVAL: COMPLAINT SAMPLE WAS NOT RETURNED TO REX FOR REVIEW. RETAIN DEVICE EVAL: NO DEVICE RETAIN EVAL PERFORMED FOR THIS LOT NUMBER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT FAILURE WAS DUE TO AN OFF LABEL USAGE OF THE DEVICE. CONCLUSION: THERE WAS NO COMPLAINT SAMPLE AVAILABLE FOR RETURN TO REX FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED TO SEE IF THERE WERE ANY ABNORMALITIES DURING THE MANUFACTURE OF THE LOT NUMBER IN QUESTION. NO ABNORMALITIES WERE DISCOVERED. A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT FAILURE WAS DUE TO AN OFF LABEL USAGE OF THE DEVICE BY THE PHYSICIAN. THE COMPLAINT FORM STATED THAT THE DEVICE WAS BEING USED IN THE PORTAL VEIN WHICH IS AN AREA NOT INDICATED FOR USE IN THE DIRECTIONS FOR USE. THIS PRODUCT COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PER THE TECHNOLOGIST: THE PHYSICIAN WAS USING A CLEANER15 TO OPEN A PORTAL VEIN AND WHEN THEY REMOVED THE CLEANER15, THEY NOTICED THE WHITE TIP WAS MISSING FROM THE DEVICE. THEY DISCONTINUED USE OF THE DEVICE ON THAT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579513 CLEANER15 ROTATIONAL THROMBECTOMY DEVICE MECHANICAL THROMBECTOMY DEVICE MCW REX MEDICAL L.P. 700015 REFX1348271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other