BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE INTRODUCER SET WITH WIRE GUIDEWIRE

    MDR report key: 5515875 · Received March 18, 2016

    Report

    Report Number
    MW5061023
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    February 26, 2016
    Report Date
    March 8, 2016
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INNER CATH OF MICROPUNCTURE SET SEPARATED, LEAVING HALF IN THE PT. CATH SNARED AND REMOVED. LARGE LEFT NECK TUMOR (METASTATIC STAGE 4 CA W/LUNG) THAT HAD PERSISTENT BLEEDING-OOZING. HAD 2 PRIOR EMBOLIZATIONS OF CAROTID ARTERY, WAS STABLE THEN OOZING AGAIN. NEEDED TO SACRIFICE THE LEFT VERTEBRAL ARTERY. DURING THE RIGHT GROIN PUNCTURE, THE MICROPUNCTURE "GOT CAUGHT UP IN RIGHT GROIN AND SHEARED OFF 4 INCHES OF CATHETER. DISTAL END STILL IN VESSEL, LEFT GROIN ACCESSED, GOOSENECK USED TO SNARE WIRE AND CATHETER AT THE ARTERIOTOMY SITE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166368 MICROPUNCTURE INTRODUCER SET WITH WIRE GUIDEWIRE SILHOUETTE TRANSITIONLESS DYB COOK MEDICAL MPS-401-U-SST 6467965

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention