BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F VECTOR JL4.0 W/SH

    MDR report key: 38349 · Received September 12, 1996

    Report

    Report Number
    1220452-1996-00001
    Event Type
    Injury
    Date Received
    September 12, 1996
    Date of Event
    August 19, 1996
    Report Date
    August 19, 1996
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATH LAB MGR REPORTED THAT THE DEVICE WAS INSERTED INTO A 57 YEAR OLD MALE PT AND IT WAS PLACED UP AND AROUND THE AORTIC ARCH. THE PHYSICIAN ATTEMPTED TO SEAT THE DEVICE IN THE ARTERY, BUT IT FOLDED OVER ON ITSELF. THE PHYSICIAN TRIED TO PLACE A .035J WIRE THROUGH THE DEVICE BUT WAS UNSUCCESSFULL. HE THEN ATTEMPTED TO PLACE A .063 WIRE THROUGH THE DEVICE AND THEN THE END OF THE DEVICE BROKE OFF IN THE PT. THE PHYSICIAN SNARED THE END OF THE BROKEN PIECE OF THE DEVICE AND BROUGHT IT DOWN TO THE FEMORAL ARTERY. THE PT WAS THEN BROUGHT TO SURGERY FOR EXTRICATION OF THE PIECE OF THE DEVICE AND BYPASS SURGERY. THE PT WAS REPORTED AS HAVING AN UNEVENTFUL RECOVERY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F VECTOR JL4.0 W/SH ANGIOPLASTY GUIDING CATHETER DYB MEDTRONIC INTERVENTIONAL VASCULAR, INC. AS8004SH 43581

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention USED WERE .035J AND.063 GUIDE