BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEANER15 ROTATIONAL THROMBECTOMY DEVICE

    MDR report key: 4435809 · Received December 23, 2014

    Report

    Report Number
    3003862657-2014-00012
    Event Type
    Death
    Date Received
    December 23, 2014
    Date of Event
    October 15, 2014
    Report Date
    December 23, 2014
    Manufacturer
    REX MEDICAL LP
    Product Code
    MCW
    PMA / PMN Number
    K120346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: NO COMPLAINT SAMPLE RETURNED FOR EVALUATION; CASE IMAGES, VIDEOS AS WELL AS PATIENT MEDICAL HISTORY IN THE PROCESS OF BEING SUBMITTED TO MANUFACTURER 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 NOT ABLE TO BE DETERMINED AT THIS TIME. 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 ONE PREVIOUS COMPLAINT FOR A PATIENT DEATH DUE TO STROKE WHERE A CLEANER15 DEVICE WAS USED IN THE CASE AND IT WAS FROM THE SAME HOSPITAL JUST ONE MONTH PRIOR TO THE DATE OF THIS EVENT. A DEFINITIVE ROOT CAUSE OF THIS PRODUCT COMPLAINT WAS NOT ABLE TO BE DETERMINED AT THIS TIME. INVESTIGATION REMAINS OPEN PENDING FURTHER INFORMATION FROM THE HOSPITAL WHERE THE REPORTED INCIDENT OCCURRED.

    Description of Event or Problem · 1

    PER THE FIELD COMPLAINT REPORT: PATIENT SHOWED SIGNS AND SYMPTOMS OF STROKE WHILE WAKING UP FROM PERCUTANEOUS THROMBECTOMY. PATIENT WAS TREATED FOR STROKE AND DIED AT THE HOSPITAL. HOSPITAL STATES THIS IS "SUSPICIOUS" AS THEY HAVE HAD TWO PATIENTS IN A MONTH PASS AFTER USING THE DEVICE. HOSPITAL ALSO SAID THEY DON'T KNOW IF THE DEVICE HAD ANYTHING TO DO WITH THE OUTCOME. A FOGARTY BALLOON ON THE ARTERIAL SIDE WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847606 CLEANER15 ROTATIONAL THROMBECTOMY DEVICE MECHANICAL THROMBECTOMY DEVICE MCW REX MEDICAL LP 700015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death