BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEANER ROTATIONAL THROMBECTOMY DEVICE

    MDR report key: 2885392 · Received November 9, 2012

    Report

    Report Number
    3003862657-2012-00004
    Event Type
    Death
    Date Received
    November 9, 2012
    Date of Event
    July 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    REX MEDICAL LP
    Product Code
    MCW
    PMA / PMN Number
    K091029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT F/U: REVIEW OF CASE IMAGES; REVIEW OF PROCEDURE NOTES; REVIEW OF POST PROCEDURE SUMMARY (ALL PERFORMED BY (B)(4)); F/U WITH DISTRIBUTOR PERSONNEL REGARDING CASE. COMPLAINT SAMPLE EVAL: THE COMPLAINT SAMPLE WAS NOT RETURNED TO REX FOR EXAM BY THE ENGINEERING TEAM. RETAIN DEVICE EVAL: THERE WERE NO RETAIN DEVICE EVALS AS THE LOT NUMBER OF THE COMPLAINT SAMPLE WAS NOT PROVIDED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOUND THIS PT DEATH WAS DUE TO PHYSICIAN ERROR. REVIEW OF CASE DOCUMENTATION FOUND THE ROOT CAUSE TO BE MANUAL MASSAGING THAT CAUSED FATAL PULMONARY EMBOLISM. ONCE CENTRAL OBSTRUCTION WAS RELIEVED, THERE WAS NOTHING TO PREVENT CLOT GOING CENTRALLY...

    Description of Event or Problem · 1

    ON (B)(6) 2012, REX MEDICAL WAS NOTIFIED OF A PT DEATH THAT OCCURRED ON (B)(6) 2012, IMMEDIATELY AFTER THE COMPLETION OF A DECLOT PROCEDURE OF A NATIVE FISTULAE THAT INVOLVED A CLEANER ROTATIONAL THROMBECTOMY DEVICE. THE PROCEDURAL NOTES FROM THE CASE AS WELL AS THE POST CASE SUMMARY AND CASE IMAGES (ALONG WITH FEEDBACK FROM DISTRIBUTION PERSONNEL) WAS AVAILABLE FOR REVIEW AND EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEANER ROTATIONAL THROMBECTOMY DEVICE MECHANICAL THROMBECTOMY DEVICE MCW REX MEDICAL LP 700009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death