BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEANER15 ROTATIONAL THROMBECTOMY DEVICE

    MDR report key: 4217417 · Received October 14, 2014

    Report

    Report Number
    3003862657-2014-00009
    Event Type
    Death
    Date Received
    October 14, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 14, 2014
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    MCW
    PMA / PMN Number
    K120346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: NO 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 AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT FAILURE WAS DUE TO AN OFF LABEL USAGE OF THE DEVICE. CONCLUSION: THE DEVICE USED FOR THIS CASE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE PERFORMED BECAUSE THE LOT NUMBER FOR THE COMPLAINT IN QUESTION WAS NOT PROVIDED. A REVIEW OF THE TREND ANALYSIS FOUND NO PREVIOUS COMPLAINTS FOR A PT DEATH WHERE A CLEANER15 DEVICE WAS USED IN THE CAUSE. A DEFINITIVE ROOT CAUSE OF THIS PRODUCT COMPLAINT WAS FOUND TO BE AN OFF LABEL USAGE OF THE DEVICE BY THE PHYSICIAN. THE USE OF A CLEANER15 DEVICE IN THE MANNER THAT WAS REPORTED (DVT) IS CONSIDERED AN OFF LABEL USAGE BECAUSE THE DEVICE IS NOT INDICATED FOR USE IN DVT OR WITHIN AN IVC WHICH ALSO CONTAINED A PREVIOUSLY IMPLANTED IVC FILTER. THEREFORE, THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PER THE FIELD COMPLAINT REPORT: DOCTOR TOLD ME HE WAS USING CLEANER 15 ON DVT IN THE IVC WITH AN IVC FILTER IN PLACE. HE SAID HE WAS BEING VERY AGGRESSIVE OPERATING THE DEVICE IN THE IVC, ALSO WITHIN THE FILTER AND ABOVE THE FILTER. HE SAID PT WAS VERY OLD. HE SAID THE PT DIES ON THE TABLE. HE SAID CLEANER OPERATED PERFECTLY AND THAT CLEANER WAS NOT AT FAULT AND THAT THIS JUST HAPPENS SOMETIMES. HE SAID HE STILL USES CLEANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651971 CLEANER15 ROTATIONAL THROMBECTOMY DEVICE MECHANICAL THROMBECTOMY DEVICE MCW REX MEDICAL, L.P. 700115 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death