BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 5238083 · Received November 19, 2015

    Report

    Report Number
    2134265-2015-08343
    Event Type
    Injury
    Date Received
    November 19, 2015
    Report Date
    October 21, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POSSIBLE PULMONARY EMBOLISM OCCURRED. THE LESION WAS LOCATED IN THE VENOUS LIMB AND THE ARTERIAL LIMB. PRIOR TO STARTING THE ARTERIOVENOUS DECLOT PROCEDURE, THE PHYSICIAN QUESTIONED THE POSSIBILITY OF AN INFECTION AT THE SITE. THE SITE WAS RED AND SWOLLEN. THE VASCULAR SURGEON MADE THE DECISION THERE WAS NO INFECTION AND THE PHYSICIAN COULD PROCEED WITH THE PROCEDURE. AN AVX THROMBECTOMY SET WAS SELECTED AND ADVANCED TO TREAT THE LESION. FOLLOWING THROMBECTOMY, ANGIOPLASTY WAS PERFORMED ON THE LESION WHEN THE PATIENT STARTED SEVERELY SHAKING. THE PATIENT DESATURATED SLIGHTLY, DEVELOPED TACHYCARDIA AND THE BLOOD PRESSURE SPIKED UPWARD. THE PROCEDURE WAS ABANDONED. THE PHYSICIAN THOUGHT THAT MAYBE THERE HAD BEEN AN INFECTION, AND THAT MAYBE PUS WAS SENT INTO THE BLOODSTREAM AND THAT THE PATIENT MIGHT BE SEPTIC. THE POSSIBILITY OF A SMALL PULMONARY EMBOLISM WAS DISCUSSED BUT THE VASCULAR SURGEON WASN'T SURE. THE PATIENT WAS STABILIZED AND ADMITTED FOR DIALYSIS AND FURTHER OBSERVATION. THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768402 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-001 0000190851

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention