BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTAL STEERABLE HYDROPHILIC GUIDEWIRE

    MDR report key: 11164795 · Received January 13, 2021

    Report

    Report Number
    3013656790-2021-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 13, 2020
    Manufacturer
    PHENOX LTD
    Product Code
    DQX
    UDI-DI
    05391530910040
    PMA / PMN Number
    K093397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA IN FOLLOWING FIELDS D2 COMMON NAME DEVICE D9 DEVICE AVAILABLE FOR EVALUATION H3 DEVICE EVALUATED BY MANUFACTURER H6 ADVERSE EVENT CODE MEDICAL DEVICE PROBLEM CODE. TYPE OF INVESTIGATION . INVESTIGATION FINDINGS. INVESTIGATIONS CONCLUSIONS.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT - SEE INTINAL REPORT FOR THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION TO BE PROVIDED PENDING DEVICE RETURN AND ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STROKE THROMBECTOMY, DR. ADVANCED A PORTAL WIRE IN A SOMEWHAT TORTUOUS ANATOMY. UPON TORQUING THE DEVICE TO THE M1 THE WIRE "POPPED". HE HAD THE WIRE INSIDE A MICROCATHETER INSIDE A GUIDE. THE FRACTURE TOOK PLACE 30CM FROM THE PROXIMAL IN THE COMMON. MICROCATHETER WAS REMOVED AND A THROMBECTOMY DEVICE WAS USED TO PIN THE WIRE FRAGMENT INSIDE OF THE GUIDE. THE WIRE WAS SUCCESSFULLY RETRIEVED WITH NO OTHER DAMAGE OR CONSEQUENCE TO THE PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54749 PORTAL STEERABLE HYDROPHILIC GUIDEWIRE CATHETER GUIDE WIRE DQX PHENOX LTD PORT-14-200-1 5090899 05391530910040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention