BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER INTRODUCER KIT

    MDR report key: 753717 · Received August 11, 2006

    Report

    Report Number
    1625425-2006-00008
    Event Type
    Injury
    Date Received
    August 11, 2006
    Manufacturer
    ARGON MEDICAL DEVICES, INC
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    TOTAL VEIN SOLUTION FIRST HEARD OF THIS EVENT IN 2006 WITH A CALL FROM A DR REPORTING THAT THE LASER FIBER BROKE OFF IN A PT. TVS REQUESTED MORE INFO AND THE SAMPLE AND DID NOT RECEIVE EITHER UNTIL THE NEXT MONTH. THEY REC'D A MAUDE REPORT ALONG WITH THE SAMPLE. AFTER WHICH THEY TOLD ARGON AND OPTICAL INTEGRITY THE CORRECT STORY INVOLVING OUR INTRODUCER. THE SAMPLE WAS FIRST SENT TO OPTICAL INTEGRITY AND THEN THE SAMPLE WAS SENT TO ARGON. ARGON AND TOTAL VEIN SOLUTIONS DETERMINED THAT THE CUSTOMER WAS IN ERROR AND WAS THE OBVIOUS CAUSE FOR THIS MALFUNCTION. THE DILATOR WAS STILL IN THE SHEATH WHEN THE PORTION WAS REMOVED FROM THE PT. ARGON'S INSERT STATES TO REMOVE THE DILATOR FROM THE SHEATH. THERE ARE PROCEDURES THAT ARE IN PLACE TO INSURE THE FIBER IS IN THE PROPER LOCATION. THIS PARTICULAR PRODUCT WAS MANUFACTURED BY ARGON MEDICAL DEVICES FOR TOTAL VEIN SOLUTIONS. THE PRODUCT IS LABELED TOTAL VEIN SOLUTION'S NAME AND ADDRESS.

    Description of Event or Problem · 1

    THE PT WAS TREATED FOR ENDOVENOUS LASER ABLATION, WENT HOME, HAS PAIN IN THE LEG AND WENT TO HOSP. AT THE HOSP, THEY DISCOVERED THAT SOMETHING WAS LEFT IN THE PT'S LEG. UPON SURGICAL REMOVAL, A PIECE OF THE DILATOR AND SEATH WAS REMOVED. IT IS UNCLEAR WHETHER A PORTION OF THE FIBER WAS LEFT IN THE PT. THE PORTION WAS REMOVED FROM THE PT AND BE RETURNED TO OPTICAL INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER INTRODUCER KIT INTRODUCER DYB ARGON MEDICAL DEVICES, INC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention