BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEWISSEN INFUSION CATHETER

    MDR report key: 16041 · Received July 21, 1994

    Report

    Report Number
    16041
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    February 3, 1994
    Report Date
    February 11, 1994
    Manufacturer
    MEDI-TECH
    Product Code
    JCY
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CATH USED BY RADIOLOGIST TO INSTILL THROMBOLYTIC MED INTO THROMBUS OCCLUDING RT. FEM/POP GRAFT. WHEN THE CATH WAS WITHDRAWN, ONE OF THE LENGTH MARKERS WAS MISSING AND COULD BE SEEN WITHIN THE VESSEL VIA FLUOROSCOPY. A LARGER SHEATH AND "STONE BASKET" INSTRUMENT WAS USED OT RETRIEVE THE MARKER WITH PROLONGED EFFORT AND MANIPULATION. THE PATIENT WAS TAKEN TO THE OR FOR GENERAL ANESTHESIA AND SURGICAL REPAIR OF THE LARGE HOLE INM THE VESSEL AND REMOVAL OF THE THROMBUS. SHE WAS DISCHARGED TO HOME ONM 2/5/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEWISSEN INFUSION CATHETER ANGIOGRAPHY INFUSION CATHETER JCY MEDI-TECH 100905

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R PERIPHERAL IV LINES