BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS (TM) SR PRO

    MDR report key: 2223125 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03467
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    October 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE, WAS RETURNED FOR EVALUATION. THE GUIDE WIRE EXIT PORT WAS LIFTED 1.0MM. A TEST GUIDE WIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDE WIRE INTO THE CATHETER AND DAMAGE WAS NOTED TO THE GUIDE WIRE EXIT PORT. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED DURING VISUAL ANALYSIS. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING VISUAL OR FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS AND ANTICIPATED PROCEDURAL COMPLICATION FOR THE PATIENT VASOSPASM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC TEST REMOVAL DIFFICULTY AND A VASOCONSTRICTION OCCURRED. THE PHYSICIAN PERFORMED A DIAGNOSTIC PROCEDURE WITH AN F/G, ATLANTIS, SR PRO DIAGNOSTIC IMAGING CATHETER IN THE LESION IN THE RIGHT CORONARY ARTERY (RCA) FROM DISTAL TO PROXIMAL. AFTER RECEIVING SATISFACTORY MEASUREMENTS THE PHYSICIAN BEGAN WITHDRAWING THE CATHETER BUT THE CATHETER "APPEARED TO BE LOOPED AROUND" CAUSING A VESSEL SPASM. THERE WERE ADJUSTMENTS MADE TO KEEP THE WIRE IN PLACE AND MEDICATION WAS ADMINISTERED TO RESOLVE THE SPASM. THE PATIENT STATUS WAS REPORTED AS FINE AND NO FURTHER INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC TEST REMOVAL DIFFICULTY AND A VASOCONSTRICTION OCCURRED. THE PHYSICIAN PERFORMED A DIAGNOSTIC PROCEDURE WITH AN F/G, ATLANTIS, SR PRO DIAGNOSTIC IMAGING CATHETER IN THE LESION IN THE RIGHT CORONARY ARTERY (RCA) FROM DISTAL TO PROXIMAL. AFTER RECEIVING SATISFACTORY MEASUREMENTS THE PHYSICIAN BEGAN WITHDRAWING THE CATHETER BUT THE CATHETER "APPEARED TO BE LOOPED AROUND" CAUSING A VESSEL SPASM. THERE WERE ADJUSTMENTS MADE TO KEEP THE WIRE IN PLACE AND MEDICATION WAS ADMINISTERED TO RESOLVE THE SPASM. THE PATIENT STATUS WAS REPORTED AS FINE AND NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS (TM) SR PRO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749389420 14422739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention