BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANER15 ROTATIONAL THROMBECTOMY DEVICE

    MDR report key: 3869501 · Received April 30, 2014

    Report

    Report Number
    3003862657-2014-00004
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    November 13, 2013
    Report Date
    March 11, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW-UP: CO COMPLAINT SAMPLE RETURNED FOR EVALUATION; NO CASE IMAGES, VIDEOS, ETC. WERE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED TO REX FOR REVIEW. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION PERFORMED FOR THIS LOT NO. 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 SAMPLED AVAILABLE FOR RETURN TO REX FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER ALSO FOUND NO ABNORMALITIES WITHIN THIS LOT DURING MANUFACTURING. A RETAIN DEVICE EVALUATION COULD NOT BE PERFORMED AS THERE WERE NO DEVICES AVAILABLE FROM THE LOT NUMBER IN QUESTION. A DEFINITIVE ROOT CAUSE OF THIS PRODUCT COMPLAINT WAS FOUND TO BE AN OFF LABEL USAGE OF THE DEVICE BY THE PHYSICIAN. USING A CLEANER DEVICE IN THE MANNER THAT WAS REPORTED (ADVANCING THE DEVICE WHILE IT WAS RUNNING AS OPPOSED TO PULLING/RETRACTING THE DEVICE WHILE OPERATING IT) IS CONSIDERED AN OFF LABEL USAGE WHICH RESULTED IN THE RADIOPAQUE TIP COMING OFF OF THE ROTATIONAL WIRE. THEREFORE, THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PER THE FIELD COMPLAINT REPORT: THE ATRAUMATIC TIP FELL OFF DURING THE CASE. AFTER GOING OVER THE CASE WITH IR DOC, WE FOUND THAT HE WAS ADVANCING DEVICE IN NATIVE VESSEL WHILE DEVICE WAS ON. THIS WAS CONTRA-INDICATED IN THE DFU AND THE PHYSICIAN HAS BEEN RE-INSERVICED AND IS NOW AWARE OF THE CORRECT INDICATION FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259091 CLEANER15 ROTATIONAL THROMBECTOMY DEVICE MECHANICAL THROMBECTOMY DEVICE MCW REX MEDICAL, L.P. 700015 REFX1348271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other