BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 2874370 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-08329
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED: PATIENT SEX, RELEVANT TESTS/LAB DATA; OTHER RELEVANT HISTORY. UPDATED/CORRECTION: DESCRIBE EVENT OR PROBLEM. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2012-06875, 2134265-2012-07357. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND DIAGNOSIS (IVUS) PROCEDURE, CATHETER PULL BACK DIFFICULTIES OCCURRED AND THROMBUS FORMED IN THE TARGET VESSEL. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE OSTIAL LEFT CIRCUMFLEX ARTERY (LCX). INITIALLY THE ILAB CART MOTORDRIVE AND THE ATLANTIS SR PRO IMAGING CATHETER FAILED TO PERFORM AN AUTOMATIC PULLPACK, BUT SUCCESSFULLY DID IT ON A THIRD ATTEMPT. AT THAT TIME THROMBUS WAS FOUND IN THE TARGET VESSEL, WHICH WAS SUCCESSFULLY EXTRACTED BY AN ASPIRATION CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE DRUG THERAPY USED DURING THE PROCEDURE WAS UNKNOWN. THE PHYSICIAN FELT THE EVENT IS CONSIDERED AS LIKELY TO BE RELATED TO THE ATLANTIS IMAGING CATHETER AND NOT THE ILAB PULLBACK FAILURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED WITH AN EPISODE OF CENTRAL CHEST DISCOMFORT. THE PATIENT DEVELOPED INFEROLATERAL ST SEGMENT DEPRESSION WITH NO SYMPTOMS. CARDIAC CATHETERIZATION WAS THEREFORE RECOMMENDED. INTRAVASCULAR ULTRASOUND CONFIRMED THAT THE MID LAD DISEASE WAS SIGNIFICANT, AND THE OSTIAL DISEASE WAS ALSO SEVERE WITH A VERY HEAVY PLAQUE BURDEN EXTENDING RIGHT BACK TO THE LEFT MAIN STEM. ANGIOGRAPHY REVEALED A FILLING DEFECT IN THE MID LAD ASSUMED TO BE A THROMBUS. HEPARIN 3,000 UNITS OVER AND ABOVE THE ORIGINAL 7,000 UNITS WAS GIVEN ALTHOUGH AN ACT CAME BACK AT 240. ABCIXIMAB WAS GIVEN AS A BOLUS AND INFUSION AND THREE EXPORT RUNS WERE UNDERTAKEN TO ASPIRATE THE CLOT. AT THE END OF THESE PROCEDURES THE LAD LOOKED SATISFACTORY WITH NO OBVIOUS THROMBUS. THE PATIENT WAS COMPLETELY ASYMPTOMATIC AND WAS TRANSFERRED BACK TO CCU. AT THIS STAGE THE PATIENT WAS RECOMMENDED FOR CORONARY ARTERY BYPASS GRAFTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) UNK428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ILAB CART, MDU| ATLANTIS IMAGING CATHETER