BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL BALLOON

    MDR report key: 4532290 · Received December 12, 2014

    Report

    Report Number
    4532290
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO FACILITY ON (B)(6) 2014 AND UNDERWENT PLE ARTERIOGRAM WITH ANGIOPLASTY; HOWEVER, DURING THE PROCEDURE, THE ANGIOPLASTY BALLOON BECAME DISLODGED INTO THE RIGHT POPLITEAL ARTERY; THUS, PATIENT WAS THEN TAKEN TO THE OR FOR RIGHT POPLITEAL FOSSA EXPLORATION AND FOREIGN BODY REMOVAL. POSTOPERATIVELY, PATIENT WENT TO THE ICU FOR CLOSE OBSERVATION. HE HAD A PALPABLE PT ON THE RIGHT AND DOPPLERABLE DPS BILATERALLY. PT WAS STARTED ON A HEPARIN GTT POSTOPERATIVELY D/T HIS CHRONIC RATE CONTROLLED AFIB. ON POD #1, PATIENT CONTINUED TO DO WELL. HAD SOME ISSUES WITH PAIN, BUT WAS BETTER CONTROLLED AFTER HIS PAIN MEDS WERE SCHEDULES. ON POD #2 PATIENT HAD A BEDSIDE ECHO PERFORMED PER CARDIOLOGY TO LOOK FOR ANY CARDIAC THROMBUS THAT COULD HAVE BEEN PRESENT. TTE WAS NONDIAGNOSTIC. ON POD #3, PATIENT WAS ABLE TO BE DISCHARGED HOME ON THERAPEUTIC LOVENOX AND COUMADIN 5MG TO BE BRIDGED AS OUTPATIENT. PULSES WERE STILL PALPABLE ON THE RIGHT, AND EXTREMITIES WERE WARM AND WELL PERFUSED. HIS PAIN WAS WELL CONTROLLED ON PO PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809680 APEX MONORAIL BALLOON ANGIOPLASTY BALLOON LOX BOSTON SCIENTIFIC 38959-1420 16577 245

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention