BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA ICE PLUS¿

    MDR report key: 7315860 · Received March 6, 2018

    Report

    Report Number
    2134265-2018-01394
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Report Date
    February 7, 2018
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DXK
    PMA / PMN Number
    K160173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE RETURNED IN THE ORIGINAL BOX, THE BOX WAS ALREADY OPENED FORM THE CLOSURE STRIP. A SIDE EDGE OF THE HAS A DAMAGE SECTION, HOWEVER, THIS DAMAGE DOES NOT PASS THROUGH THE BOX CARTON, IT'S A DAMAGE IN THE SURFACE OF THE BOX. INSIDE THE BOX ALL THE COMPONENTS AND THE DEVICE WERE IN THEIR SEALED POUCH AND WAS NOT DAMAGE ON THEM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS HANDLING DAMAGE AS THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE OR PORTION OF THE DEVICE WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE PACKAGING WAS COMPROMISED. DURING UNPACKING OF THE ULTRA ICE PLUS¿ IMAGING CATHETER A 1 CM SLIT WAS FOUND IN THE PART WHERE IT WILL BE OPENED. NO PATIENT INVOLVEMENT AS THE DEVICE COULD NOT BE DELIVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE PACKAGING WAS COMPROMISED. DURING UNPACKING OF THE ULTRA ICE PLUS¿ IMAGING CATHETER A 1 CM SLIT WAS FOUND IN THE PART WHERE IT WILL BE OPENED. NO PATIENT INVOLVEMENT AS THE DEVICE COULD NOT BE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161189 ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC DXK BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00499120 0021395014

    Patients

    Seq Age Sex Outcome Treatment
    1