BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA ICE PLUS¿

    MDR report key: 7362456 · Received March 22, 2018

    Report

    Report Number
    2134265-2018-02275
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 20, 2018
    Report Date
    February 27, 2018
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DXK
    UDI-DI
    08714729904380
    PMA / PMN Number
    K160173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT : OVER 18 YEARS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. NO ISSUES WERE NOTED UPON VISUAL INSPECTION. THE CATHETER WAS FLUSHED NORMALLY UPON FUNCTIONAL INSPECTION AND NO ISSUES WERE NOTED. THE IMPEDANCE TESTING SHOWED A GOOD UNIT WAVE FORM. GOOD SQUARE IMAGE APPEARED IN THE ILAB SYSTEM UPON IMAGE CHARACTERIZATION TESTING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS NOT CONFIRMED - RETURNED AS THERE WAS NO EVIDENCE OF EITHER THE ALLEGED ISSUE(S) OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE A FOREIGN SUBSTANCE WAS NOTED. AN ULTRA ICE PLUS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE WATER INJECTED TO THE TIP OF THE CATHETER LOOKED CLOUDY. FURTHERMORE, THE DEVICE WAS INSERTED TO THE PATIENT'S BODY BUT PHYSICIAN DISCONTINUED THE USAGE AND REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE A FOREIGN SUBSTANCE WAS NOTED. AN ULTRA ICE PLUS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE WATER INJECTED TO THE TIP OF THE CATHETER LOOKED CLOUDY. FURTHERMORE, THE DEVICE WAS INSERTED TO THE PATIENT'S BODY BUT PHYSICIAN DISCONTINUED THE USAGE AND REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206373 ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC DXK BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00499120 20881358 08714729904380

    Patients

    Seq Age Sex Outcome Treatment
    1